COAT-A-COUNT FREE ESTRIOL— 510(k) K932989

Name: FDA 510(k) clearance K932989
Creator: U.S. Food and Drug Administration
Published: 1994-12-19

Substantially Equivalent

Diagnostic Products Corp.

FDA 510(k) clearance K932989 for COAT-A-COUNT FREE ESTRIOL, Substantially Equivalent on 1994-12-19. Applicant: Diagnostic Products Corp.. Device class: 1.

Clearance details

Applicant: Diagnostic Products Corp.
Product code: Code CGI
Device class: Class 1
Regulation: 21 CFR 862.1265
Advisory panel: Clinical Chemistry
Date received: 1993-06-18
Decision date: 1994-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

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