Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Vitek Systems, Inc.

FDA 510(k) & PMA Approved Devices — 39 products

Total Devices39
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K920661 VIDAS CMV IGG ASSAYLFZ1993-02-12 View
510(k) K921302 VITEK IMMUNODIAGNOSTIC ASSAY SYSTEMJHI1992-07-28 View
510(k) K921176 VITEK IMMUNODIAGNOSTIC ASSAY SYSTEMCEP1992-04-08 View
510(k) K920952 VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERRITINE ASSAYDBF1992-04-07 View
510(k) K915884 VIDAS CHLAMYDIA ASSAY, MODIFICATIONLJC1992-03-04 View
510(k) K905211 VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAYLLH1991-10-11 View
510(k) K912371 BIOMERIEUX RSV DIRECT IF KITLKT1991-09-23 View
510(k) K910230 LYME-SPOT IF KITLSR1991-08-30 View
510(k) K910210 SLIDEX MENINGITE-KIT 5GTJ1991-08-12 View
510(k) K910304 RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIALQL1991-07-26 View
510(k) K911429 VITEK GRAM NEGATIVE IDENTIFICATION CARD, MODIFIEDLQM1991-06-24 View
510(k) K910499 IMMUNODIAGNOSTIC ASSAY SYSTEM HERPES SIMPLEX VIRUSLGC1991-05-01 View
510(k) K905787 VIDAS CHLAMYDIA ASSAY VITEK IMMUNDIAG ASSAY SYSTLJC1991-04-29 View
510(k) K910666 VITEK ANAEROBE IDENTIFICATION CARD, MODIFICATIONJSP1991-04-03 View
510(k) K895805 SLIDEX ROTA-KIT 2LIQ1991-02-26 View
510(k) K905020 SLIDEX STREPTO-KITGTY1991-01-28 View
510(k) K902925 VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) (RBG)LFX1990-08-09 View
510(k) K900996 VITEK ANAEROBE IDENTIFICATION CARDJSP1990-05-11 View
510(k) K900818 VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) TOXO.LGD1990-04-30 View
510(k) K896097 VIDAS RESPIRATORY SYNCYTIAL VIRUS (RSV) ASSAYGQG1990-02-26 View
↑