VITEK GRAM NEGATIVE IDENTIFICATION CARD, MODIFIED— 510(k) K911429

Name: FDA 510(k) clearance K911429
Creator: U.S. Food and Drug Administration
Published: 1991-06-24

Substantially Equivalent

Vitek Systems, Inc.

FDA 510(k) clearance K911429 for VITEK GRAM NEGATIVE IDENTIFICATION CARD, MODIFIED, Substantially Equivalent on 1991-06-24. Applicant: Vitek Systems, Inc.. Device class: 1.

Clearance details

Applicant: Vitek Systems, Inc.
Product code: Code LQM
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1991-03-26
Decision date: 1991-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hazelwood, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LQM

view all

K923313 — ROCHE OXI/FERM II1993-04-05
K925915 — VITEK RAPID CALL-GRAM NEGATIV IDENT CARD1993-03-23
K912897 — SCEPTOR IDENTIFICATION SYSTEM1991-10-28
K890057 — SENSITITRE AUTO ID PLATE AP801989-06-09
K862642 — GRAM NEGATIVE FLUORESCENT IDENTIFICATION PANEL1986-09-11

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.