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

Vitek Systems, Inc. — Predicate Candidate Screening

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

85 daysmedian FDA review time

260 days90th percentile

39clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K920661	VIDAS CMV IGG ASSAY	Vitek Systems, Inc.	1993-02-12	365	1
K921302	VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM	Vitek Systems, Inc.	1992-07-28	131	0
K921176	VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM	Vitek Systems, Inc.	1992-04-08	28	1
K920952	VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERRITINE ASSAY	Vitek Systems, Inc.	1992-04-07	41	0
K915884	VIDAS CHLAMYDIA ASSAY, MODIFICATION	Vitek Systems, Inc.	1992-03-04	83	1
K905211	VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAY	Vitek Systems, Inc.	1991-10-11	325	0
K912371	BIOMERIEUX RSV DIRECT IF KIT	Vitek Systems, Inc.	1991-09-23	117	0
K910230	LYME-SPOT IF KIT	Vitek Systems, Inc.	1991-08-30	224	0
K910210	SLIDEX MENINGITE-KIT 5	Vitek Systems, Inc.	1991-08-12	209	0
K910304	RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIA	Vitek Systems, Inc.	1991-07-26	183	0
K911429	VITEK GRAM NEGATIVE IDENTIFICATION CARD, MODIFIED	Vitek Systems, Inc.	1991-06-24	90	0
K910499	IMMUNODIAGNOSTIC ASSAY SYSTEM HERPES SIMPLEX VIRUS	Vitek Systems, Inc.	1991-05-01	85	0
K905787	VIDAS CHLAMYDIA ASSAY VITEK IMMUNDIAG ASSAY SYST	Vitek Systems, Inc.	1991-04-29	123	1
K910666	VITEK ANAEROBE IDENTIFICATION CARD, MODIFICATION	Vitek Systems, Inc.	1991-04-03	51	0
K895805	SLIDEX ROTA-KIT 2	Vitek Systems, Inc.	1991-02-26	516	0
K905020	SLIDEX STREPTO-KIT	Vitek Systems, Inc.	1991-01-28	82	0
K902925	VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) (RBG)	Vitek Systems, Inc.	1990-08-09	37	0
K900996	VITEK ANAEROBE IDENTIFICATION CARD	Vitek Systems, Inc.	1990-05-11	70	0
K900818	VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) TOXO.	Vitek Systems, Inc.	1990-04-30	68	0
K896097	VIDAS RESPIRATORY SYNCYTIAL VIRUS (RSV) ASSAY	Vitek Systems, Inc.	1990-02-26	129	0
K891385	VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS)	Vitek Systems, Inc.	1989-04-18	40	0
K883558	VITEK GRAM-NEGATIVE IDENTIFICATION CARD	Vitek Systems, Inc.	1988-09-16	28	0
K883279	PHASE II FSH KIT	Vitek Systems, Inc.	1988-09-09	37	0
K882252	PHASE II LH KIT	Vitek Systems, Inc.	1988-08-04	65	0
K881925	VITEK YEAST BIOCHEMICAL CARD	Vitek Systems, Inc.	1988-06-16	38	0
K843686	AMS ANA CARD	Vitek Systems, Inc.	1984-12-12	85	0
K842587	GNC PLUS	Vitek Systems, Inc.	1984-07-20	17	0
K834389	AMS GRAM-POSITIVE IDENT. CARD	Vitek Systems, Inc.	1984-03-09	86	0
K834269	AMS GRAM-NEGATIVE IDENT. CARD	Vitek Systems, Inc.	1984-03-09	92	0
K820264	AMS GRAM-POSITIVE IDENTIFICATION CARD	Vitek Systems, Inc.	1982-05-03	90	0
K792231	AMS YEAST BIOCHEMICAL CARD	Vitek Systems, Inc.	1979-12-19	44	0
K791932	AMS ENTEROBACTERIACEASE CARE	Vitek Systems, Inc.	1979-11-13	47	0
K782056	CORD, ENTEROBACTERIACEAE BIOCHEMICAL	Vitek Systems, Inc.	1979-01-26	46	0
K780731	LIDOCAINE CALIBRATOR KIT	Vitek Systems, Inc.	1979-01-17	260	0
K780961	THEOPHYLLINE CONTROL SERUM	Vitek Systems, Inc.	1978-12-07	178	0
K780960	SERUM, CONTROL, DRUGS, ANTIARRYTHMIC	Vitek Systems, Inc.	1978-12-07	178	0
K780732	PROCAINAMIDE CALIBRATOR KIT	Vitek Systems, Inc.	1978-11-22	204	0
K780734	ANTICONVULSANTS II CALIBRATOR KIT	Vitek Systems, Inc.	1978-06-22	51	0
K780733	ANTICONVULSANTS III CALIBRATOR KIT	Vitek Systems, Inc.	1978-06-22	51	0

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