Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

39 results for "Vitek Systems, Inc."
1–24 of 39
Search insights Median review: 85d Cleared: 100% Top manufacturer: Vitek Systems, Inc. Lead specialty: Microbiology
Cleared Feb 12, 1993
VIDAS CMV IGG ASSAY
K920661 · LFZ
Vitek Systems, Inc.
Microbiology · 365d
Cleared Jul 28, 1992
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM
K921302 · JHI
Vitek Systems, Inc.
Chemistry · 131d
Cleared Apr 08, 1992
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM
K921176 · CEP
Vitek Systems, Inc.
Chemistry · 28d
Cleared Apr 07, 1992
VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERRITINE ASSAY
K920952 · DBF
Vitek Systems, Inc.
Immunology · 41d
Cleared Mar 04, 1992
VIDAS CHLAMYDIA ASSAY, MODIFICATION
K915884 · LJC
Vitek Systems, Inc.
Microbiology · 83d
Cleared Oct 11, 1991
VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAY
K905211 · LLH
Vitek Systems, Inc.
Microbiology · 325d
Cleared Sep 23, 1991
BIOMERIEUX RSV DIRECT IF KIT
K912371 · LKT
Vitek Systems, Inc.
Microbiology · 117d
Cleared Aug 30, 1991
LYME-SPOT IF KIT
K910230 · LSR
Vitek Systems, Inc.
Microbiology · 224d
Cleared Aug 12, 1991
SLIDEX MENINGITE-KIT 5
K910210 · GTJ
Vitek Systems, Inc.
Microbiology · 209d
Cleared Jul 26, 1991
RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIA
K910304 · LQL
Vitek Systems, Inc.
Microbiology · 183d
Cleared Jun 24, 1991
VITEK GRAM NEGATIVE IDENTIFICATION CARD, MODIFIED
K911429 · LQM
Vitek Systems, Inc.
Microbiology · 90d
Cleared May 01, 1991
IMMUNODIAGNOSTIC ASSAY SYSTEM HERPES SIMPLEX VIRUS
K910499 · LGC
Vitek Systems, Inc.
Microbiology · 85d
Cleared Apr 29, 1991
VIDAS CHLAMYDIA ASSAY VITEK IMMUNDIAG ASSAY SYST
K905787 · LJC
Vitek Systems, Inc.
Microbiology · 123d
Cleared Apr 03, 1991
VITEK ANAEROBE IDENTIFICATION CARD, MODIFICATION
K910666 · JSP
Vitek Systems, Inc.
Microbiology · 51d
Cleared Feb 26, 1991
SLIDEX ROTA-KIT 2
K895805 · LIQ
Vitek Systems, Inc.
Microbiology · 516d
Cleared Jan 28, 1991
SLIDEX STREPTO-KIT
K905020 · GTY
Vitek Systems, Inc.
Microbiology · 82d
Cleared Aug 09, 1990
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) (RBG)
K902925 · LFX
Vitek Systems, Inc.
Microbiology · 37d
Cleared May 11, 1990
VITEK ANAEROBE IDENTIFICATION CARD
K900996 · JSP
Vitek Systems, Inc.
Microbiology · 70d
Cleared Apr 30, 1990
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) TOXO.
K900818 · LGD
Vitek Systems, Inc.
Microbiology · 68d
Cleared Feb 26, 1990
VIDAS RESPIRATORY SYNCYTIAL VIRUS (RSV) ASSAY
K896097 · GQG
Vitek Systems, Inc.
Microbiology · 129d
Cleared Apr 18, 1989
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS)
K891385 · DEW
Vitek Systems, Inc.
Chemistry · 40d
Cleared Sep 16, 1988
VITEK GRAM-NEGATIVE IDENTIFICATION CARD
K883558 · JSS
Vitek Systems, Inc.
Microbiology · 28d
Cleared Sep 09, 1988
PHASE II FSH KIT
K883279 · CGJ
Vitek Systems, Inc.
Chemistry · 37d
Cleared Aug 04, 1988
PHASE II LH KIT
K882252 · CEP
Vitek Systems, Inc.
Chemistry · 65d