Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Bayer Diagnostics Corp. — Predicate Candidate Screening

32 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

60 daysmedian FDA review time

168 days90th percentile

32clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K033379	BAYER SPECIAL CHEMISTRY CONTROLS	Bayer Diagnostics Corp.	2003-12-19	58	0
K033380	BAYER SPECIAL CHEMISTRY CALIBRATORS	Bayer Diagnostics Corp.	2003-12-16	55	0
K033007	BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM	Bayer Diagnostics Corp.	2003-11-14	49	0
K031857	ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY	Bayer Diagnostics Corp.	2003-09-04	80	0
K022096	URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM	Bayer Diagnostics Corp.	2003-03-18	264	0
K030452	BAYER LIGAND PLUS 1, 2, 3 CONTROLS	Bayer Diagnostics Corp.	2003-03-03	20	0
K023840	ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650	Bayer Diagnostics Corp.	2003-01-07	50	0
K023841	AMMONIA ASSAY FOR THE ADVIA 1650	Bayer Diagnostics Corp.	2002-12-24	36	0
K022177	PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRAT	Bayer Diagnostics Corp.	2002-12-17	167	0
K022329	CA 125 II ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM	Bayer Diagnostics Corp.	2002-11-27	132	0
K023184	ETHANOL ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM	Bayer Diagnostics Corp.	2002-11-18	55	0
K022178	CA 15-3 ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM	Bayer Diagnostics Corp.	2002-11-12	132	0
K022668	ADVIA 120 HEMATOLOGY SYSTEM COMPLETE BLOOD COUNT (CBC) METHO	Bayer Diagnostics Corp.	2002-10-15	64	0
K020807	AFP ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM	Bayer Diagnostics Corp.	2002-10-01	203	0
K022968	ADVIA TESTPOINT CSF CONTROL	Bayer Diagnostics Corp.	2002-09-24	18	0
K022331	ADVIA 120 HEMATOLOGY SYSTEM, CEREBROSPINAL FLUID METHOD	Bayer Diagnostics Corp.	2002-09-11	55	0
K020616	BAYER RAPIDPOINT 405 SYSTEM	Bayer Diagnostics Corp.	2002-07-17	142	2
K021151	AMMONIA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM	Bayer Diagnostics Corp.	2002-07-13	94	0
K020794	SALICYLATE ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM	Bayer Diagnostics Corp.	2002-07-11	122	0
K020792	ACETAMINOPHEN ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM	Bayer Diagnostics Corp.	2002-07-11	122	0
K021535	ADVIA CANTAUR AND ACS:180 INSULIN CALIBRATOR	Bayer Diagnostics Corp.	2002-06-27	48	2
K021532	ADVIA CENTAUR AND ACS:180 C-PEPTIDE CALIBRATOR	Bayer Diagnostics Corp.	2002-06-27	48	0
K020217	ACS:180 AND ADVIA CENTAUR IPTH IMMUNOASSAY	Bayer Diagnostics Corp.	2002-03-15	52	4
K012357	CA 15-3 ASSAY FOR THE ADVIA CENTAUR SYSTEM	Bayer Diagnostics Corp.	2002-02-28	218	0
K013959	BAYER VALPROIC ACID ASSAY FOR THE ACS:180 AND ADVIA CENTAUR	Bayer Diagnostics Corp.	2002-01-29	60	0
K013750	ADVIA 1650 CHOLINESTERASE ASSAY	Bayer Diagnostics Corp.	2002-01-18	66	0
K012183	BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGG ASSAY	Bayer Diagnostics Corp.	2001-12-27	168	0
K013606	ACS 180 HOMOCYSTEINE ASSAY	Bayer Diagnostics Corp.	2001-12-21	51	0
K013406	ADVIA CENTAUR HOMOCYSTEINE ASSAY	Bayer Diagnostics Corp.	2001-12-18	64	2
K012904	ADVIA 120 HEMATOLOGY SYSTEM, CYANIDE-FREE HIGH DETERMINATION	Bayer Diagnostics Corp.	2001-09-21	23	0
K010050	ADVIA CENTAUR AND ACS: 180 FOLATE IMMUNOASSAY	Bayer Diagnostics Corp.	2001-02-05	31	14
K003291	BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR ANTI-TPO ASSAY	Bayer Diagnostics Corp.	2000-12-05	46	2

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda