Medical Device Manufacturer · US , Mchenry , IL

American Diagnostic Corp.

39 submissions · 39 cleared · Since 1980
39
Total
39
Cleared
0
Denied

American Diagnostic Corp. — FDA 510(k) Submissions

American Diagnostic Corp. has submitted 39 FDA 510(k) premarket notifications since 1980, of which 39 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Stethoscope, Electronic, Method, Enzymatic, Glucose (urinary, Non-quantitative), Test, Qualitative And Quantitative Factor Deficiency, Radioimmunoassay, Total Triiodothyronine, Calculator/data Processing Module, For Clinical Use . Use the specialty filter in the sidebar to narrow results.

39 devices
1–25 of 39
Adscope 658 Electronic Stethoscope
K162589 · DQD Stethoscope, Electronic · Cardiovascular
Mar 2017 175d
OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS
K093495 · HLJ Ophthalmoscope,... · Ophthalmic
Nov 2010 374d
ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK
K060321 · DQD Stethoscope, Electronic · Chemistry
May 2006 95d
ADC 656 ELECTRONIC STETHOSCOPE
K012304 · DQD Stethoscope, Electronic · Cardiovascular
Nov 2001 104d
ANEROID AND MERCURIAL SPHYGMOMANOMETERS
K962655 · DXQ Blood Pressure Cuff · Cardiovascular
Jan 1997 203d
ELECTRONIC THERMOMETERS
K940686 · FLL Continuous Measurement... · General Hospital
Jul 1994 142d
PROSCOPES AND ADSCOPES
K935944 · LDE Stethoscope, Manual · Cardiovascular
Mar 1994 80d
COAGULATION REFERENCE PLASMA, NORMAL
K932145 · GIZ Plasma, Control, Normal · Hematology
Oct 1993 167d
BIOTEL MICROALBUMINURIA (TM)
K894169 · JIR Indicator Method, Protein... · Chemistry
Sep 1989 95d
ACTICHROME ATIII KIT
K893608 · JBQ Antithrombin Iii... · Hematology
Jun 1989 44d
RELLPLATE C KIT, RELLPLATE C BULK PLATES
K884940 · GGP Test, Qualitative And... · Hematology
Mar 1989 105d
ACTICLOT C KIT
K884941 · GGP Test, Qualitative And... · Hematology
Mar 1989 105d
MAJOR QUALITY GLUCOSE AND KETONES URINE TEST
K870500 · JIL Method, Enzymatic,... · Chemistry
Mar 1987 30d
BIOTEL (TM)/ DIABETES
K855239 · JIL Method, Enzymatic,... · Chemistry
Jun 1986 164d
BIOTEL (TM)/UTI
K855238 · JMT Diazo (colorimetric),... · Chemistry
May 1986 129d
BIOTEL (TM)/ KIDNEY
K855237 · KHE Reagent, Occult Blood · Hematology
May 1986 126d
QUINIDINE FLUORESCENT IMMUNOASSAY
K832493 · LBZ Enzyme Immunoassay,... · Chemistry
Sep 1983 47d
IGE RADIOIMMUNOASSAY KIT
K831377 · DGC Ige, Antigen, Antiserum,... · Chemistry
Jun 1983 36d
KENAMYCIN FLUORESCENT IMMUNOASSAY FIA
K823062 · KJI Radioimmunoassay, Kanamycin · Chemistry
Nov 1982 23d
NETILMICIN FLUORESCENT IMMUNOASSAY
K822941 · LCE Radioimmunoassay,... · Chemistry
Oct 1982 22d
LIDOCAINE FLUORESCENT IMMUNOASSAY
K822347 · KLR Enzyme Immunoassay,... · Toxicology
Aug 1982 19d
VANCOMYCIN FLUORESCENT IMMUNOASSAY
K822308 · LEH Radioimmunoassay, Vancomycin · Toxicology
Aug 1982 13d
PRIMIDONE FLUORESCENT IMMUNOASSAY
K822229 · LFT Fluorescent Immunoassay,... · Toxicology
Aug 1982 16d
CARBAMAZEPINE FLOURESCENT IMMUNOASSAY
K821945 · KLT Enzyme Immunoassay,... · Toxicology
Jul 1982 17d
AMERIFLOUR FLUOROMETER
K821807 · JQP Calculator/data... · Chemistry
Jul 1982 15d
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