SR1 ESTRADIOL ENZYME IMMUNOASSAY— 510(k) K911396

Substantially Equivalent

Serono-Baker Diagnostics, Inc.

FDA 510(k) clearance K911396 for SR1 ESTRADIOL ENZYME IMMUNOASSAY, Substantially Equivalent on 1991-05-28. Applicant: Serono-Baker Diagnostics, Inc..

Clearance details

Applicant: Serono-Baker Diagnostics, Inc.
Product code: Code CHP
Advisory panel: Clinical Chemistry
Date received: 1991-03-29
Decision date: 1991-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allentown, PA, US

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