510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K974721Substantially Equivalent

Unconjugated Estriol Assay for the Bayer Immuno 1 System (in Vitro Diagnostic System)

Bayer Corp., Tarrytown NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K974721 is the FDA 510(k) clearance record for UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM), a class I device, cleared for Bayer Corp. on under FDA product code CGI (Radioimmunoassay, Estriol). FDA records list 63 510(k) clearances for Bayer Corp., from to . As of , FDA records show no recalls naming K974721.

Clearance record

Decision date
Received
(75 days to decision)
Product code
CGI Radioimmunoassay, Estriol
Regulation
21 CFR 862.1265
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Bayer Corp. 511 Benedict Ave., Tarrytown NY
510(k) summary
Summary
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