VIDAS ROTAVIRUS ASSAY— 510(k) K965092

Substantially Equivalent

Biomerieux Vitek, Inc.

FDA 510(k) clearance K965092 for VIDAS ROTAVIRUS ASSAY, Substantially Equivalent on 1997-05-05. Applicant: Biomerieux Vitek, Inc.. Device class: 1.

Clearance details

Applicant: Biomerieux Vitek, Inc.
Product code: Code LIQ
Device class: Class 1
Regulation: 21 CFR 866.3405
Advisory panel: Microbiology
Date received: 1996-12-19
Decision date: 1997-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockland, MA, US

Download summary PDF View on FDA.gov ↗

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K964424 — ROTAVIRUS EIA1997-08-08
K951208 — ROTA-DAN RAPID ROTAVIRUS EIA KIT1996-02-14

More clearances from Biomerieux Vitek, Inc.

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K955627 — VIDAS CHLAMYDIA BLOCKING ASSAY1996-10-07
K962549 — VIDAS CREATINE KINASE MB ASSAY 30-4211996-08-30
K962609 — GRAM NEGATIVE IDENTIFICATION PLUS CARD1996-08-30

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