Medical Device Manufacturer · US , Mchenry , IL

Isolab, Inc. - FDA 510(k) Cleared Devices

44 submissions · 44 cleared · Since 1977
44
Total
44
Cleared
0
Denied

Isolab, Inc. has 44 FDA 510(k) cleared medical devices. Based in Mchenry, US.

Historical record: 44 cleared submissions from 1977 to 1996. Primary specialty: Chemistry.

Browse the FDA 510(k) cleared devices submitted by Isolab, Inc. Filter by specialty or product code using the sidebar.

44 devices
1–12 of 44
ISOLAB'S T4 TEST KIT
K951014 · KLI Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine · Chemistry
Oct 1996 592d
NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT
K950481 · JIA Enzymatic Methods, Galactose · Chemistry
Feb 1996 363d
PHENYLALANINE TEST KIT
K943547 · JNB Ninhydrin And L-leucyl-l-alanine (fluorimetric), Phenylalanine · Chemistry
Jan 1996 554d
ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 800, 4000 SAMPLE
K950803 · JJT Enzyme Controls (assayed And Unassayed) · Chemistry
Sep 1995 212d
FLUOROSCAN NEONATAL
K950415 · KHO Fluorometer, For Clinical Use · Chemistry
Sep 1995 217d
QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLS
K942222 · JCM Control, Hemoglobin, Abnormal · Hematology
Jan 1995 259d
QUIK-SEP QUANTITATIVE HEMOGLOBIN S ASSAY
K942276 · GIQ Hemoglobin S · Hematology
Jan 1995 255d
ISOSCAN
K944185 · JQT Densitometer/scanner (integrating, Reflectance, Tlc, Radiochromat.) Clinica · Chemistry
Nov 1994 83d
RESOLVE SYSTEMS ALKALINE PHOSPHATASE TEST KIT
K934013 · CIN Electrophoretic Separation, Alkaline Phosphatase Isoenzymes · Chemistry
Apr 1994 251d
HEMOCARD, HEMOGLOBIN C ASSAY
K923153 · MLL Hemoglobin C (abnormal Hemoglobin Variant) · Hematology
Jan 1994 577d
HEMOCARD CONTROL HB-AA, AE, FAA, FAE
K931234 · JCM Control, Hemoglobin, Abnormal · Chemistry
May 1993 62d
HEMOCARD HEMOGLOBIN E
K930070 · CKA Nadh Oxidation/nad Reduction, Alt/sgpt · Hematology
Apr 1993 92d

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All44 Chemistry 22 Hematology 18 Microbiology 2 General & Plastic Surgery 1 Immunology 1