VITEK YEAST BIOCHEMICAL CARD— 510(k) K881925

Name: FDA 510(k) clearance K881925
Creator: U.S. Food and Drug Administration
Published: 1988-06-16

Substantially Equivalent

Vitek Systems, Inc.

FDA 510(k) clearance K881925 for VITEK YEAST BIOCHEMICAL CARD, Substantially Equivalent on 1988-06-16. Applicant: Vitek Systems, Inc.. Device class: 1.

Clearance details

Applicant: Vitek Systems, Inc.
Product code: Code JXB
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1988-05-09
Decision date: 1988-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hazelwood, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JXB

view all

K080719 — YEAST TRAFFIC LIGHT PNA FISH2008-09-12
K062461 — C. ALBICANS PNA FISH2006-10-25
K993554 — YEASTEST2000-02-10
K943621 — RAPID YEAST PLUS SYSTEM1995-01-27
K935124 — BACTICARD CANDIDA1994-02-25

More clearances from Vitek Systems, Inc.

view all

K920661 — VIDAS CMV IGG ASSAY1993-02-12
K921302 — VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM1992-07-28
K921176 — VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM1992-04-08
K920952 — VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERRITINE ASSAY1992-04-07
K915884 — VIDAS CHLAMYDIA ASSAY, MODIFICATION1992-03-04

Data sourced from openFDA. This site is unofficial and independent of the FDA.