ADENOLEX (R) LATEX AGGLUTINATION TEST— 510(k) K864645

Substantially Equivalent

Orion Diagnostica, Inc.

FDA 510(k) clearance K864645 for ADENOLEX (R) LATEX AGGLUTINATION TEST, Substantially Equivalent on 1987-06-04. Applicant: Orion Diagnostica, Inc..

Clearance details

Applicant: Orion Diagnostica, Inc.
Product code: Code GOD
Advisory panel: Microbiology
Date received: 1986-11-25
Decision date: 1987-06-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerset, NJ, US

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