510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K812768Substantially Equivalent

Coat-a-Count Free & Total Estriol Kit

Siemens Healthcare Diagnostics Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K812768 is the FDA 510(k) clearance record for COAT-A-COUNT FREE & TOTAL ESTRIOL KIT, a class I device, cleared for Diagnostic Products Corp. on under FDA product code CGI (Radioimmunoassay, Estriol). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics Inc., from to . As of , FDA records show no recalls naming K812768.

Clearance record

Decision date
Received
(105 days to decision)
Product code
CGI Radioimmunoassay, Estriol
Regulation
21 CFR 862.1265
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Diagnostic Products Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code CGI

Trailing 12 months

FDA records hold no clearances under product code CGI in the trailing twelve months.

FDA records show no clearances under product code CGI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CGI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260