Medical Device Manufacturer · US , Mchenry , IL

Immunotech Corp.

37 submissions · 37 cleared · Since 1980
37
Total
37
Cleared
0
Denied

Immunotech Corp. — FDA 510(k) Submissions

Immunotech Corp. has submitted 37 FDA 510(k) premarket notifications since 1980, of which 37 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Counter, Differential Cell, Radioimmunoassay, Total Triiodothyronine, Radioimmunoassay, Thyroid-stimulating Hormone, Enzyme Immunoassay, Digoxin, Radioimmunoassay, Total Thyroxine . Use the specialty filter in the sidebar to narrow results.

37 devices
1–25 of 37
OPTICLONE IGG1 FITC/IGG2A PE ISOTYPIC CONTROL
K954188 · GKZ Counter, Differential Cell · Hematology
Nov 1995 58d
OPTICLONE CD4FITC/CD8 PE MONOCLONAL ANTIBODIES
K952789 · GKZ Counter, Differential Cell · Hematology
Aug 1995 56d
OPTICLONE CD3/CD4 MONOCLONAL ANTIBODIES
K950626 · GKZ Counter, Differential Cell · Hematology
May 1995 84d
PROGESTERONE RADIOIMMUNOASSAY KIT
K931228 · JLS Radioimmunoassay,... · Chemistry
Oct 1993 226d
MICROZYME(TM) FREE T4 ENZYME IMMUNOASSAY TEST
K911634 · CEC Radioimmunoassay, Free... · Chemistry
Jun 1991 74d
MICROZYME PHENCYCLIDINE ENZYME IMMUNOASSAY TEST KT
K911153 · LCM Enzyme Immunoassay,... · Toxicology
Jun 1991 95d
MICROZYME TSH ENZYME IMMUNOASSAY KIT
K910411 · JLW Radioimmunoassay,... · Chemistry
Apr 1991 64d
MICROZYME THYROID UPTAKE ENZYME IMMUNOASSAY KIT
K905777 · CEE Radioimmunoassay,... · Immunology
Jan 1991 34d
MICROZYME(TM) METHAMPHET/AMPHET ENZYME IMMUNO KIT
K903993 · DKZ Enzyme Immunoassay,... · Chemistry
Dec 1990 113d
MICROZYME T3 ENZYME IMMUNOASSAY KIT
K904820 · CDP Radioimmunoassay, Total... · Immunology
Dec 1990 55d
MICROZYME THC ENZYME IMMUNOASSAY TEST KIT
K904635 · LDJ Enzyme Immunoassay,... · Toxicology
Nov 1990 21d
EZ-BEAD TSH ENZYME IMMUNOASSAY KIT
K903725 · JLW Radioimmunoassay,... · Chemistry
Oct 1990 71d
SEROTONIN ENZYME IMMUNOASSAY
K903609 · CDA Acid, Nitrous And... · Chemistry
Oct 1990 74d
MICROZYME UNCONJUGATED ESTRIOL ENZYME IMMUNO KIT
K903359 · CGI Radioimmunoassay, Estriol · Chemistry
Aug 1990 28d
MICROZYME T4 ENZYME IMMUNOASSAY KIT
K902922 · CDX Radioimmunoassay, Total... · Chemistry
Jul 1990 24d
MICRO DAU OPIATE ENZYME IMMUNOASSAY KIT
K902194 · DJG Enzyme Immunoassay, Opiates · Toxicology
Jul 1990 62d
EZ-BEAD PHENYTOIN ENZYME IMMUNOASSAY KIT
K901080 · DIP Enzyme Immunoassay,... · Chemistry
May 1990 71d
MICRO DAU BENZODIAZEPINE ENZYME IMMUNOASSAY KIT
K896780 · JXM Enzyme Immunoassay,... · Toxicology
Mar 1990 109d
MICRO DAU COCAINE METABOLITE TEST KIT
K896781 · DIO Enzyme Immunoassay,... · Toxicology
Mar 1990 109d
IMMUNOTECH HDL-CHOLESTEROL TEST
K900036 · LBS Ldl & Vldl Precipitation,... · Chemistry
Mar 1990 66d
IMMUNOTECH CHOLESTEROL TEST
K897036 · CHH Enzymatic... · Chemistry
Mar 1990 78d
EZ-BEAD DIGOXIN EIA KIT
K893843 · KXT Enzyme Immunoassay, Digoxin · Toxicology
Sep 1989 126d
EZ-BEAD THEOPHYLLINE ENZYME IMMUNOASSAY KIT
K881257 · KLS Enzyme Immunoassay,... · Toxicology
May 1988 65d
IMMUBEAD THYROID UPTAKE
K872172 · KHQ Radioassay,... · Chemistry
Aug 1987 70d
IMMUBEAD T3 ENZYME IMMUNOASSAY KIT
K872191 · CDP Radioimmunoassay, Total... · Chemistry
Aug 1987 66d
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