COAT-A-COUNT FREE & TOTAL ESTRIOL KIT— 510(k) K812768

Name: FDA 510(k) clearance K812768
Creator: U.S. Food and Drug Administration
Published: 1982-01-18

Substantially Equivalent

Diagnostic Products Corp.

FDA 510(k) clearance K812768 for COAT-A-COUNT FREE & TOTAL ESTRIOL KIT, Substantially Equivalent on 1982-01-18. 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: 1981-10-05
Decision date: 1982-01-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CGI

view all

K974721 — UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)1998-03-03
K962875 — ACTIVE ULTRASENSITIVE UNCONJUGATED ESTRIOL EIA1996-08-23
K955356 — ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOL1996-05-15
K932989 — COAT-A-COUNT FREE ESTRIOL1994-12-19
K944490 — AUTODELFIA UNCONJUGATED ESTRIOL (UE3) KIT1994-12-09

More clearances from Diagnostic Products Corp.

view all

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