RESPIRALEX LATEX AGGLUTINATION TEST— 510(k) K844399

Substantially Equivalent

Orion Diagnostica, Inc.

FDA 510(k) clearance K844399 for RESPIRALEX LATEX AGGLUTINATION TEST, Substantially Equivalent on 1985-01-08. Applicant: Orion Diagnostica, Inc..

Clearance details

Applicant: Orion Diagnostica, Inc.
Product code: Code GTZ
Advisory panel: Microbiology
Date received: 1984-11-13
Decision date: 1985-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerset, NJ, US

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