SR1 (FSH) IMMUNOENZYMETRIC ASSAY— 510(k) K892706

Name: FDA 510(k) clearance K892706
Creator: U.S. Food and Drug Administration
Published: 1989-06-09

Substantially Equivalent

Serono-Baker Diagnostics, Inc.

FDA 510(k) clearance K892706 for SR1 (FSH) IMMUNOENZYMETRIC ASSAY, Substantially Equivalent on 1989-06-09. Applicant: Serono-Baker Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Serono-Baker Diagnostics, Inc.
Product code: Code CGJ
Device class: Class 1
Regulation: 21 CFR 862.1300
Advisory panel: Clinical Chemistry
Date received: 1989-04-14
Decision date: 1989-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allentown, PA, US

Download summary PDF View on FDA.gov ↗

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