510(k) K915164— SRI TESTOSTERONE ENZYME IMMUNOASSAY

Substantially Equivalent

Serono-Baker Diagnostics, Inc.

Clearance details

Applicant: Serono-Baker Diagnostics, Inc.
Product code: Code CDZ
Advisory panel: Clinical Chemistry
Date received: 1991-11-14
Decision date: 1992-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allentown, PA, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.