SLIDEX MENINGITE-KIT 5— 510(k) K910210

Substantially Equivalent

Vitek Systems, Inc.

FDA 510(k) clearance K910210 for SLIDEX MENINGITE-KIT 5, Substantially Equivalent on 1991-08-12. Applicant: Vitek Systems, Inc.. Device class: 2.

Clearance details

Applicant: Vitek Systems, Inc.
Product code: Code GTJ
Device class: Class 2
Regulation: 21 CFR 866.3390
Advisory panel: Microbiology
Date received: 1991-01-15
Decision date: 1991-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hazelwood, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GTJ

K952791 — DIRECTIGEN MENINGITIS COMBO TEST1996-05-30
K915330 — DIRECTIGEN MENINGITIS COMBO TEST KIT1992-03-23
K885004 — BACTIGEN(R) N. MENINGITIDIS1989-02-07
K870089 — IMMUNOSCAN(TM) DIRECT NEISSERIA MENINGITIDIS KIT1987-03-17
K854851 — WELLCOGEN N. MENINGITIDIS B/E. COLI K1 ZL241986-02-04

More clearances from Vitek Systems, Inc.

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.