Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Immunotech Corp. — Predicate Candidate Screening

37 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

64 daysmedian FDA review time

109 days90th percentile

37clearances measured

K-number	Device	Applicant	Decided	Review days
K954188	OPTICLONE IGG1 FITC/IGG2A PE ISOTYPIC CONTROL	Immunotech Corp.	1995-11-03	58
K952789	OPTICLONE CD4FITC/CD8 PE MONOCLONAL ANTIBODIES	Immunotech Corp.	1995-08-14	56
K950626	OPTICLONE CD3/CD4 MONOCLONAL ANTIBODIES	Immunotech Corp.	1995-05-05	84
K931228	PROGESTERONE RADIOIMMUNOASSAY KIT	Immunotech Corp.	1993-10-22	226
K911634	MICROZYME(TM) FREE T4 ENZYME IMMUNOASSAY TEST	Immunotech Corp.	1991-06-24	74
K911153	MICROZYME PHENCYCLIDINE ENZYME IMMUNOASSAY TEST KT	Immunotech Corp.	1991-06-18	95
K910411	MICROZYME TSH ENZYME IMMUNOASSAY KIT	Immunotech Corp.	1991-04-03	64
K905777	MICROZYME THYROID UPTAKE ENZYME IMMUNOASSAY KIT	Immunotech Corp.	1991-01-30	34
K903993	MICROZYME(TM) METHAMPHET/AMPHET ENZYME IMMUNO KIT	Immunotech Corp.	1990-12-20	113
K904820	MICROZYME T3 ENZYME IMMUNOASSAY KIT	Immunotech Corp.	1990-12-18	55
K904635	MICROZYME THC ENZYME IMMUNOASSAY TEST KIT	Immunotech Corp.	1990-11-01	21
K903725	EZ-BEAD TSH ENZYME IMMUNOASSAY KIT	Immunotech Corp.	1990-10-26	71
K903609	SEROTONIN ENZYME IMMUNOASSAY	Immunotech Corp.	1990-10-22	74
K903359	MICROZYME UNCONJUGATED ESTRIOL ENZYME IMMUNO KIT	Immunotech Corp.	1990-08-22	28
K902922	MICROZYME T4 ENZYME IMMUNOASSAY KIT	Immunotech Corp.	1990-07-27	24
K902194	MICRO DAU OPIATE ENZYME IMMUNOASSAY KIT	Immunotech Corp.	1990-07-17	62
K901080	EZ-BEAD PHENYTOIN ENZYME IMMUNOASSAY KIT	Immunotech Corp.	1990-05-17	71
K896780	MICRO DAU BENZODIAZEPINE ENZYME IMMUNOASSAY KIT	Immunotech Corp.	1990-03-23	109
K896781	MICRO DAU COCAINE METABOLITE TEST KIT	Immunotech Corp.	1990-03-23	109
K900036	IMMUNOTECH HDL-CHOLESTEROL TEST	Immunotech Corp.	1990-03-09	66
K897036	IMMUNOTECH CHOLESTEROL TEST	Immunotech Corp.	1990-03-06	78
K893843	EZ-BEAD DIGOXIN EIA KIT	Immunotech Corp.	1989-09-28	126
K881257	EZ-BEAD THEOPHYLLINE ENZYME IMMUNOASSAY KIT	Immunotech Corp.	1988-05-27	65
K872172	IMMUBEAD THYROID UPTAKE	Immunotech Corp.	1987-08-17	70
K872191	IMMUBEAD T3 ENZYME IMMUNOASSAY KIT	Immunotech Corp.	1987-08-13	66
K872192	IMMUBEAD T4 ENZYME IMMUNOASSAY KIT	Immunotech Corp.	1987-08-13	66
K852995	ENDAB PHENOBARBITAL	Immunotech Corp.	1985-08-12	28
K851980	ENDAB TSH	Immunotech Corp.	1985-05-31	24
K840902	ENDAB ESTRIOL UNCONJUGATED	Immunotech Corp.	1984-04-18	50
K834049	ENDAB T3	Immunotech Corp.	1984-01-30	68
K822684	ENDAB THYROID UPTAKE	Immunotech Corp.	1982-10-08	35
K821141	ENDAB T4 ENZYME IMMUNOASSAY KIT	Immunotech Corp.	1982-05-13	22
K812054	ENDAB DIGOXIN KIT	Immunotech Corp.	1981-08-12	22
K810192	ENDAB CORTISOL KIT	Immunotech Corp.	1981-02-06	14
K803296	ENDAB CHOLYLGLYCINE ENZYME IMMUNO. KIT	Immunotech Corp.	1981-01-16	17
K802461	ENDAB DIGITOXIN ENZYME IMMUNOASSAY KIT	Immunotech Corp.	1980-10-31	23
K802066	ENDAB THEOPHYLLINE ENZYME IMMUNOASSAY	Immunotech Corp.	1980-10-23	57

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda