ROTALEX LATEX AGGLUTINATION TEST— 510(k) K841319

Name: FDA 510(k) clearance K841319
Creator: U.S. Food and Drug Administration
Published: 1984-09-14

Substantially Equivalent

Orion Diagnostica, Inc.

FDA 510(k) clearance K841319 for ROTALEX LATEX AGGLUTINATION TEST, Substantially Equivalent on 1984-09-14. 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: 1984-04-02
Decision date: 1984-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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