ESTRIOL RIA KIT FOR USE WITH GAMMAFLO— 510(k) K801424

Name: FDA 510(k) clearance K801424
Creator: U.S. Food and Drug Administration
Published: 1980-07-21

Substantially Equivalent

Squibb & Sons, Inc.

FDA 510(k) clearance K801424 for ESTRIOL RIA KIT FOR USE WITH GAMMAFLO, Substantially Equivalent on 1980-07-21. Applicant: Squibb & Sons, Inc.. Device class: 1.

Clearance details

Applicant: Squibb & Sons, Inc.
Product code: Code CGI
Device class: Class 1
Regulation: 21 CFR 862.1265
Advisory panel: Clinical Chemistry
Date received: 1980-06-17
Decision date: 1980-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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