510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K012337Substantially Equivalent

Bayer Advia Ims System; C-Reactive Protein System

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

K012337 is the FDA 510(k) clearance record for BAYER ADVIA IMS SYSTEM; C-REACTIVE PROTEIN SYSTEM, a class II device, cleared for Bayer Corp. on under FDA product code DCN (System, Test, C-Reactive Protein). FDA records list 63 510(k) clearances for Bayer Corp., from to . As of , FDA records show no recalls naming K012337.

Clearance record

Decision date
Received
(135 days to decision)
Product code
DCN System, Test, C-Reactive Protein
Regulation
21 CFR 866.5270
Device class
Class II
Review panel
Immunology
Applicant
Bayer Corp. 511 Benedict Ave., Tarrytown NY
510(k) summary
Summary
Third party review
No

Clearances, product code DCN

Trailing 12 months

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

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