ELISA TUBE FSH TEST KIT ENZYME LINKED IMMUN. ASSAY— 510(k) K920917

Name: FDA 510(k) clearance K920917
Creator: U.S. Food and Drug Administration
Published: 1992-03-26

Substantially Equivalent

Bio Clinic Co.

FDA 510(k) clearance K920917 for ELISA TUBE FSH TEST KIT ENZYME LINKED IMMUN. ASSAY, Substantially Equivalent on 1992-03-26. Applicant: Bio Clinic Co.. Device class: 1.

Clearance details

Applicant: Bio Clinic Co.
Product code: Code CGJ
Device class: Class 1
Regulation: 21 CFR 862.1300
Advisory panel: Clinical Chemistry
Date received: 1992-02-28
Decision date: 1992-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MI, US

Download summary PDF View on FDA.gov ↗

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