ROTAVIRUS EIA— 510(k) K964424

Substantially Equivalent

Trinity Biotech, Inc.

FDA 510(k) clearance K964424 for ROTAVIRUS EIA, Substantially Equivalent on 1997-08-08. Applicant: Trinity Biotech, Inc.. Device class: 1.

Clearance details

Applicant: Trinity Biotech, Inc.
Product code: Code LIQ
Device class: Class 1
Regulation: 21 CFR 866.3405
Advisory panel: Microbiology
Date received: 1996-11-05
Decision date: 1997-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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K951208 — ROTA-DAN RAPID ROTAVIRUS EIA KIT1996-02-14

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