ESTRIOL-SQUIBB RIA KIT— 510(k) K802455

Name: FDA 510(k) clearance K802455
Creator: U.S. Food and Drug Administration
Published: 1980-10-31

Substantially Equivalent

E. R. Squibb & Sons, Inc.

FDA 510(k) clearance K802455 for ESTRIOL-SQUIBB RIA KIT, Substantially Equivalent on 1980-10-31. Applicant: E. R. Squibb & Sons, Inc.. Device class: 1.

Clearance details

Applicant: E. R. Squibb & Sons, Inc.
Product code: Code CGI
Device class: Class 1
Regulation: 21 CFR 862.1265
Advisory panel: Clinical Chemistry
Date received: 1980-10-08
Decision date: 1980-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

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