Medical Device Manufacturer · US , Mchenry , IL

Immunotech Corp. - FDA 510(k) Cleared Devices

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

FDA 510(k) Regulatory Record - Immunotech Corp. Chemistry

18 devices
1-18 of 18
Cleared Oct 22, 1993
PROGESTERONE RADIOIMMUNOASSAY KIT
K931228 · JLS
Chemistry · 226d
Cleared Jun 24, 1991
MICROZYME(TM) FREE T4 ENZYME IMMUNOASSAY TEST
K911634 · CEC
Chemistry · 74d
Cleared Apr 03, 1991
MICROZYME TSH ENZYME IMMUNOASSAY KIT
K910411 · JLW
Chemistry · 64d
Cleared Dec 20, 1990
MICROZYME(TM) METHAMPHET/AMPHET ENZYME IMMUNO KIT
K903993 · DKZ
Chemistry · 113d
Cleared Oct 26, 1990
EZ-BEAD TSH ENZYME IMMUNOASSAY KIT
K903725 · JLW
Chemistry · 71d
Cleared Oct 22, 1990
SEROTONIN ENZYME IMMUNOASSAY
K903609 · CDA
Chemistry · 74d
Cleared Aug 22, 1990
MICROZYME UNCONJUGATED ESTRIOL ENZYME IMMUNO KIT
K903359 · CGI
Chemistry · 28d
Cleared Jul 27, 1990
MICROZYME T4 ENZYME IMMUNOASSAY KIT
K902922 · CDX
Chemistry · 24d
Cleared May 17, 1990
EZ-BEAD PHENYTOIN ENZYME IMMUNOASSAY KIT
K901080 · DIP
Chemistry · 71d
Cleared Mar 09, 1990
IMMUNOTECH HDL-CHOLESTEROL TEST
K900036 · LBS
Chemistry · 66d
Cleared Mar 06, 1990
IMMUNOTECH CHOLESTEROL TEST
K897036 · CHH
Chemistry · 78d
Cleared Aug 17, 1987
IMMUBEAD THYROID UPTAKE
K872172 · KHQ
Chemistry · 70d
Cleared Aug 13, 1987
IMMUBEAD T3 ENZYME IMMUNOASSAY KIT
K872191 · CDP
Chemistry · 66d
Cleared Aug 13, 1987
IMMUBEAD T4 ENZYME IMMUNOASSAY KIT
K872192 · KLI
Chemistry · 66d
Cleared May 31, 1985
ENDAB TSH
K851980 · JLW
Chemistry · 24d
Cleared Apr 18, 1984
ENDAB ESTRIOL UNCONJUGATED
K840902 · CGI
Chemistry · 50d
Cleared Jan 30, 1984
ENDAB T3
K834049 · CDP
Chemistry · 68d
Cleared Jan 16, 1981
ENDAB CHOLYLGLYCINE ENZYME IMMUNO. KIT
K803296 · KWW
Chemistry · 17d
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