ROTALEX 2 LATEX AGGLUTINATION TEST FOR ROTAVIRUS— 510(k) K854129

Name: FDA 510(k) clearance K854129
Creator: U.S. Food and Drug Administration
Published: 1986-01-21

Substantially Equivalent

Orion Diagnostica, Inc.

FDA 510(k) clearance K854129 for ROTALEX 2 LATEX AGGLUTINATION TEST FOR ROTAVIRUS, Substantially Equivalent on 1986-01-21. Applicant: Orion Diagnostica, Inc.. Device class: 1.

Clearance details

Applicant: Orion Diagnostica, Inc.
Product code: Code LIQ
Device class: Class 1
Regulation: 21 CFR 866.3405
Advisory panel: Microbiology
Date received: 1985-10-09
Decision date: 1986-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerset, NJ, US

Download summary PDF View on FDA.gov ↗

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