Medical Device Manufacturer · US , Mchenry , IL

Vitek Systems, Inc.

39 submissions · 39 cleared · Since 1978
39
Total
39
Cleared
0
Denied

Vitek Systems, Inc. — FDA 510(k) Submissions

Vitek Systems, Inc. has submitted 39 FDA 510(k) premarket notifications since 1978, of which 39 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Discs, Strips And Reagents, Microorganism Differentiation, Kit, Identification, Enterobacteriaceae, Kit, Anaerobic Identification, Kit, Identification, Yeast, Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) . Use the specialty filter in the sidebar to narrow results.

39 devices
1–25 of 39
VIDAS CMV IGG ASSAY
K920661 · LFZ Enzyme Linked... · Microbiology
Feb 1993 365d
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM
K921302 · JHI Visual, Pregnancy Hcg,... · Chemistry
Jul 1992 131d
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM
K921176 · CEP Radioimmunoassay,... · Chemistry
Apr 1992 28d
VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERRITINE ASSAY
K920952 · DBF Ferritin, Antigen,... · Immunology
Apr 1992 41d
VIDAS CHLAMYDIA ASSAY, MODIFICATION
K915884 · LJC Enzyme Linked... · Microbiology
Mar 1992 83d
VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAY
K905211 · LLH Reagents, Clostridium... · Microbiology
Oct 1991 325d
BIOMERIEUX RSV DIRECT IF KIT
K912371 · LKT Respiratory Syncytial... · Microbiology
Sep 1991 117d
LYME-SPOT IF KIT
K910230 · LSR Reagent, Borrelia... · Microbiology
Aug 1991 224d
SLIDEX MENINGITE-KIT 5
K910210 · GTJ Antisera, All Groups, N.... · Microbiology
Aug 1991 209d
RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIA
K910304 · LQL Gram Positive... · Microbiology
Jul 1991 183d
VITEK GRAM NEGATIVE IDENTIFICATION CARD, MODIFIED
K911429 · LQM Gram Negative... · Microbiology
Jun 1991 90d
IMMUNODIAGNOSTIC ASSAY SYSTEM HERPES SIMPLEX VIRUS
K910499 · LGC Enzyme Linked... · Microbiology
May 1991 85d
VIDAS CHLAMYDIA ASSAY VITEK IMMUNDIAG ASSAY SYST
K905787 · LJC Enzyme Linked... · Microbiology
Apr 1991 123d
VITEK ANAEROBE IDENTIFICATION CARD, MODIFICATION
K910666 · JSP Kit, Anaerobic... · Microbiology
Apr 1991 51d
SLIDEX ROTA-KIT 2
K895805 · LIQ Enzyme Linked... · Microbiology
Feb 1991 516d
SLIDEX STREPTO-KIT
K905020 · GTY Antigens, All Groups,... · Microbiology
Jan 1991 82d
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) (RBG)
K902925 · LFX Enzyme Linked... · Microbiology
Aug 1990 37d
VITEK ANAEROBE IDENTIFICATION CARD
K900996 · JSP Kit, Anaerobic... · Microbiology
May 1990 70d
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) TOXO.
K900818 · LGD Enzyme Linked... · Microbiology
Apr 1990 68d
VIDAS RESPIRATORY SYNCYTIAL VIRUS (RSV) ASSAY
K896097 · GQG Antigen, Cf (including Cf... · Microbiology
Feb 1990 129d
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS)
K891385 · DEW Igg, Antigen, Antiserum,... · Chemistry
Apr 1989 40d
VITEK GRAM-NEGATIVE IDENTIFICATION CARD
K883558 · JSS Kit, Identification,... · Microbiology
Sep 1988 28d
PHASE II FSH KIT
K883279 · CGJ Radioimmunoassay,... · Chemistry
Sep 1988 37d
PHASE II LH KIT
K882252 · CEP Radioimmunoassay,... · Chemistry
Aug 1988 65d
VITEK YEAST BIOCHEMICAL CARD
K881925 · JXB Kit, Identification, Yeast · Microbiology
Jun 1988 38d
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