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

Immulok, Inc. — Predicate Candidate Screening

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

44 daysmedian FDA review time

92 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days
K830971	HERPES SIMPLEX VIRUS TYPING REAGENTS	Immulok, Inc.	1983-06-30	94
K830342	CULUTURE SET CHLAMYDIA ISOLATION AND	Immulok, Inc.	1983-05-04	92
K830250	CVT VIRAL TRANSPORTS	Immulok, Inc.	1983-02-28	34
K823304	RIASET PROLACTIN RIA KIT	Immulok, Inc.	1982-12-22	47
K822785	FLUOROSET IMMUNOFLUORESCENT ANTIBODY	Immulok, Inc.	1982-11-29	76
K823055	FLOUROSET IMMUNOFLUORESCENT ANTIBODY	Immulok, Inc.	1982-11-05	18
K822606	CYTOMEGALOVIRUS ANTOBODY IGG	Immulok, Inc.	1982-11-01	66
K822605	TOXOPLASMA GONDII ANTIBODY IGG	Immulok, Inc.	1982-10-27	61
K822607	ANTINUCLEAR ANTOBODY CELL SUBSTRATE	Immulok, Inc.	1982-09-17	21
K821411	HISTOSET IMMUNOPEROFIDASE TISSUE	Immulok, Inc.	1982-06-25	44
K821567	IMMULOK CULTURESET	Immulok, Inc.	1982-06-25	31
K820390	HISTOSET IMMUNOPEROXIDASE TISSURE KIT	Immulok, Inc.	1982-04-14	63
K812821	H-103 IGG, H-104 IGA, H-105 IGM	Immulok, Inc.	1981-10-26	19
K812497	IMMULIK STAIN PLATE	Immulok, Inc.	1981-09-23	23
K811721	H-101 KAPPA,H-102 LAMBDA,H-107 LYSOZME	Immulok, Inc.	1981-07-16	28

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