ELECSYS PSA ASSAY— 510(k) K964351

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K964351 for ELECSYS PSA ASSAY, Substantially Equivalent on 1997-07-25. Applicant: Boehringer Mannheim Corp..

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code LTJ
Advisory panel: Immunology
Date received: 1996-11-01
Decision date: 1997-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Concord, CA, US

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