PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST— 510(k) K984346

Substantially Equivalent

Meridian Diagnostics, Inc.

FDA 510(k) clearance K984346 for PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST, Substantially Equivalent on 1999-06-25. Applicant: Meridian Diagnostics, Inc..

Clearance details

Applicant: Meridian Diagnostics, Inc.
Product code: Code LGC
Advisory panel: Microbiology
Date received: 1998-12-04
Decision date: 1999-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, US

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