Medical Device Manufacturer · US , Mchenry , IL

Diagnostic Products Corp.

321 submissions · 321 cleared · Since 1976
321
Total
321
Cleared
0
Denied

Diagnostic Products Corp. — FDA 510(k) Submissions

Diagnostic Products Corp. has submitted 321 FDA 510(k) premarket notifications since 1976, of which 321 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Test, Radioallergosorbent (rast) Immunological, Radioimmunoassay, Testosterones And Dihydrotestosterone, Radioimmunoassay, Parathyroid Hormone, Single (specified) Analyte Controls (assayed And Unassayed), Radioimmunoassay, Thyroid-stimulating Hormone . Use the specialty filter in the sidebar to narrow results.

321 devices
1–25 of 321
IMMULITE 2000, IMMULITE 2500 VANCOMYCIN
K063045 · LEH Radioimmunoassay, Vancomycin · Toxicology
Dec 2006 62d
IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I
K034055 · JHX Fluorometric Method, Cpk... · Chemistry
Jan 2004 22d
IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER
K033234 · DHA System, Test, Human... · Chemistry
Dec 2003 67d
IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE
K032881 · CDZ Radioimmunoassay,... · Chemistry
Oct 2003 25d
IMMULITE 2000 ALLERGEN-SPECIFIC IGE
K023152 · DHB System, Test,... · Immunology
Dec 2002 85d
IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL
K023304 · JKR Radioimmunoassay, Calcitonin · Chemistry
Dec 2002 67d
IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER
K022603 · CEW Radioimmunoassay,... · Toxicology
Aug 2002 15d
IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS)
K022118 · JHX Fluorometric Method, Cpk... · Chemistry
Jul 2002 21d
ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS)
K021257 · LKJ Antinuclear Antibody,... · Immunology
Jun 2002 45d
IMMULITE 2000 SPECIFIC ALLERGENS
K021206 · DHB System, Test,... · Immunology
May 2002 44d
IMMULITE 2000 MIXED ALLERGEN PANELS
K021208 · DHB System, Test,... · Immunology
May 2002 44d
IMMULITE BR-MA, MODEL #LKBR; IMMULITE 2000 BR-MA, MODEL #L2KBR
K013984 · MOI System, Test,... · Immunology
Mar 2002 115d
IMMULITE TOXOPLASMA IGM, MODEL LKTM1 AND LKTM2, IMMULITE 2000 TOXOPLASMA IGM, MODEL L2KTM2 AND L2KTM6
K012075 · LGD Enzyme Linked... · Microbiology
Jan 2002 192d
IMMULITE RUBELLA IGM,LKRM1, LKRM2, IMMULITE 2000 RUBELLA IGM, MODEL L2KRM2, L2KRM6
K012077 · LFX Enzyme Linked... · Microbiology
Jan 2002 192d
IMMULITE INTACT PTH, IMMULITE 2000 INTACT PTH, MODELS LKPP1 (100 TESTS), LKPP5 (500 TESTS), L2KPP2 (200 TESTS), L2KPP6
K013566 · CEW Radioimmunoassay,... · Chemistry
Nov 2001 25d
IMMUNLITE 2000 ALLERGEN-SPECIFIC IGE AND MIXED ALLERGEN PANELS, MODEL L2KUN6 (600 TESTS)
K013135 · DHB System, Test,... · Immunology
Oct 2001 30d
IMMULITE 2000 ALLERGEN-SPECIFIC IGE AND SPECIFIC ALLERGENS, MDOEL L2KUN6 (600 TESTS)
K013134 · DHB System, Test,... · Immunology
Oct 2001 26d
IMMULITE 2000 DIGOXIN, MODELS L2KDI2 (200 TESTS) AND L2KDI6 (600 TESTS)
K012301 · KXT Enzyme Immunoassay, Digoxin · Toxicology
Sep 2001 61d
IMMULITE 2000 GENTAMICIN, MODELS L2KGE2 (200 TESTS), L2KGE6 (600 TESTS)
K012311 · LCD Enzyme Immunoassay,... · Chemistry
Aug 2001 28d
IMMULITE 2000 TOBRAMYCN, MODELS L2KTC2 (2002 TESTS), L2KTC6 (600 TESTS)
K012312 · KLB Radioimmunoassay, Tobramycin · Toxicology
Aug 2001 28d
IMMULITE INTACT PTH, MODEL LKPP1 (100 TESTS), LKPP5 (500 TESTS), IMMULITE 2000 INTACT PTH, MODEL L2KPP (200 TESTS), L2K6
K011505 · CEW Radioimmunoassay,... · Chemistry
Jul 2001 47d
MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6
K010878 · LGC Enzyme Linked... · Microbiology
Apr 2001 30d
IMMULITE CK-MB, MODEL LKMB1 (100 TESTS), LKMB5 (500 TESTS); IMMULITE 2000 CK-MB, MODEL L2KMB2 (200 TESTS), L2KMB6 (600)
K004002 · JHX Fluorometric Method, Cpk... · Chemistry
Feb 2001 50d
IMMULITE HOMOCYSTEINE MODEL LKHO1 / IMMULITE 2000 HOMOCYSTEINE MODEL L2KHO2
K003597 · LPS Urinary Homocystine... · Toxicology
Feb 2001 76d
IMMULITE HIGH SENSITIVITY CRP, IMMULITE 2000 HIGH SENSITIVITY CRP
K003372 · DCN System, Test, C-reactive... · Immunology
Dec 2000 57d

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