510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K012357Substantially Equivalent

Ca 15-3 Assay for the Advia Centaur System

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

K012357 is the FDA 510(k) clearance record for CA 15-3 ASSAY FOR THE ADVIA CENTAUR SYSTEM, a class II device, cleared for Bayer Diagnostics Corp. on under FDA product code MOI (System, Test, Immunological, Antigen, Tumor). FDA records list 32 510(k) clearances for Bayer Diagnostics Corp., from to . As of , FDA records show no recalls naming K012357.

Clearance record

Decision date
Received
(218 days to decision)
Product code
MOI System, Test, Immunological, Antigen, Tumor
Regulation
21 CFR 866.6010
Device class
Class II
Review panel
Immunology
Applicant
Bayer Diagnostics Corp. 511 Benedict Ave., Tarrytown NY
510(k) summary
Summary
Third party review
No

Clearances, product code MOI

Trailing 12 months

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

FDA records show no clearances under product code MOI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MOI, 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