ELECSYS TESTOSTERONE ASSAY— 510(k) K964889

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K964889 for ELECSYS TESTOSTERONE ASSAY, Substantially Equivalent on 1997-03-18. Applicant: Boehringer Mannheim Corp..

Clearance details

Applicant
Boehringer Mannheim Corp.
Product code
Code CDZ
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Concord, CA, US
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