TESTOSTERONE SEROZYME(TM) ENZYME IMMUNOASSAY— 510(k) K924257

Substantially Equivalent

Serono-Baker Diagnostics, Inc.

FDA 510(k) clearance K924257 for TESTOSTERONE SEROZYME(TM) ENZYME IMMUNOASSAY, Substantially Equivalent on 1992-11-30. Applicant: Serono-Baker Diagnostics, Inc..

Clearance details

Applicant: Serono-Baker Diagnostics, Inc.
Product code: Code CDZ
Advisory panel: Clinical Chemistry
Date received: 1992-08-24
Decision date: 1992-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allentown, PA, US

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