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

Baxter Diagnostics, Inc. — Predicate Candidate Screening

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

113 daysmedian FDA review time

349 days90th percentile

72clearances measured

K-number	Device	Applicant	Decided	Review days
K934458	DRIED GRAM-POSITIVE MIC/COMBO PANELS	Baxter Diagnostics, Inc.	1995-07-18	673
K950817	DRIED GRAM POSITIVE MIC/COMBO PANELS/PNEUMOCOCCI	Baxter Diagnostics, Inc.	1995-04-25	62
K935704	DRIED GRAM-NEGATIVE MIC//COMBO PANELS	Baxter Diagnostics, Inc.	1995-04-14	500
K950570	STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAY	Baxter Diagnostics, Inc.	1995-04-11	67
K945235	DRIED GRAM-POSITIVE MIC/COMBO PANELS	Baxter Diagnostics, Inc.	1995-03-07	131
K941030	DRIED GRAM-NEGATIVE CEFPODOXIME	Baxter Diagnostics, Inc.	1995-02-16	349
K940917	LORACARBEF GRAM-NAGATIVE PANELS	Baxter Diagnostics, Inc.	1995-02-08	348
K941459	GRAM POSITIVE DRIED OVERNIGHT PANELS/LOMEFLOX	Baxter Diagnostics, Inc.	1995-02-03	316
K941317	DRIED GRAM NEGATIVE/CEFMETAZOLE	Baxter Diagnostics, Inc.	1995-01-31	319
K942267	DRIED GRAM-POSITIVE MIC/COMBO PANELS/CEFMETAZOLE	Baxter Diagnostics, Inc.	1995-01-09	244
K942089	MICRODILUTION/LORACARBEF PANELS	Baxter Diagnostics, Inc.	1995-01-09	252
K943510	DRIED GRAM-POSITIVE MIC/COMBO PANELS	Baxter Diagnostics, Inc.	1994-12-02	135
K935702	DADE INNOVIN II	Baxter Diagnostics, Inc.	1994-11-22	357
K933414	STRATUS(R) THYROID UPTAKE FLUOR ENZYME IMMUNOASSAY	Baxter Diagnostics, Inc.	1994-11-22	497
K935307	DADE(R) THROMBIN-ANTITHROMBIN (TAT) COMPLEX ELISA	Baxter Diagnostics, Inc.	1994-11-22	385
K934003	STRATUS DIGOXIN FLOUROMETRIC ENZYME IMMUNOASSAY	Baxter Diagnostics, Inc.	1994-11-22	462
K944651	DRIED GRAM-POSITIVE MIC/COMBO PANELS	Baxter Diagnostics, Inc.	1994-11-18	53
K934323	DRIED GRAM-POSITIVE MIC/COMBO PANELS, AMP/EXT DIL	Baxter Diagnostics, Inc.	1994-10-19	411
K935987	FLEXTRANS	Baxter Diagnostics, Inc.	1994-08-15	244
K936196	ANTITHROMBIN III CHROMOGENIC ASSAY	Baxter Diagnostics, Inc.	1994-05-04	126
K934275	PARAMAX ALCOHOL REAGENT	Baxter Diagnostics, Inc.	1994-04-26	238
K935568	PARAMAX PHENOBARBITAL REAGENT AND CALIBRATORS	Baxter Diagnostics, Inc.	1994-03-11	113
K932686	PARAMAX(R) PHENYTOIN REAGENT	Baxter Diagnostics, Inc.	1993-11-26	176
K933437	DADE ANEMIA/HEMOCHROMATOSIS CONTOLS,LEVEL 1,LEVEL 2,AND LEVE	Baxter Diagnostics, Inc.	1993-10-28	106
K932912	STRATUS FREE THYROXINE (FREE T4) FLUOROMETRIC	Baxter Diagnostics, Inc.	1993-10-28	134
K933464	STRATUS ESTRADIOL FLUOROMETRIC ENZYME IMMUNOASSAY	Baxter Diagnostics, Inc.	1993-10-22	98
K933635	STRATUS PROGESTERONE FLOUROMETRIC IMMUNOASSAY	Baxter Diagnostics, Inc.	1993-10-08	73
K932685	PARAMAX(R) THEOPHYLLINE REAGENT AND CALIBRATORS	Baxter Diagnostics, Inc.	1993-09-24	113
K933435	DADE URINE CHEMISTRY CONTROL, LEVEL 1 & LEVEL 2	Baxter Diagnostics, Inc.	1993-09-24	72
K933188	DADE (PAI-1) CHROMOGENIC ASSAY DADE COAGTROL-PAI	Baxter Diagnostics, Inc.	1993-09-22	84
K933426	STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO	Baxter Diagnostics, Inc.	1993-08-26	44
K924919	DADE(R) TUMOR MARKER CONTROL	Baxter Diagnostics, Inc.	1993-08-05	310
K932082	DRIED GRAM-NEGATIVE MIC/COMBO PANELS	Baxter Diagnostics, Inc.	1993-07-20	81
K922582	BARTELS CYTOMEGALOVIRUS IGG EIA	Baxter Diagnostics, Inc.	1993-04-08	316
K922580	BARTELS CYTOMEGALOVIRUS IGM EIA	Baxter Diagnostics, Inc.	1993-04-08	316
K926545	DRIED GRAM-NEGATIVE MIC/COMBO PANELS	Baxter Diagnostics, Inc.	1993-03-26	85
K922482	MICROSCAN DRI GRAM POSIT/GRAM NEGA MIC/COMBO PANEL	Baxter Diagnostics, Inc.	1993-03-12	289
K925452	DADE HEPZYME	Baxter Diagnostics, Inc.	1993-01-11	75
K926046	DADE(R) CK-MB/MYOGLOBIN IMMUN CONTROL, I,II,III	Baxter Diagnostics, Inc.	1993-01-05	35
K922334	BARTELS HERPES SIMPLEX VIRUS 1 IGM EIA	Baxter Diagnostics, Inc.	1992-12-15	216
K922333	BARTELS HERPES SIMPLEX VIRUS 2 IGM EIA	Baxter Diagnostics, Inc.	1992-12-15	216
K924074	STRATUS VITAMIN B12 FLUOROMETRIC ENZYME-LINKED	Baxter Diagnostics, Inc.	1992-10-26	75
K922073	STRATUS BHCG FLUOROMETRIC ENZYME IMMUNOASSAY	Baxter Diagnostics, Inc.	1992-10-19	168
K922583	BARTELS HERPES SIMPLEX VIRUS 2 IGG EIA	Baxter Diagnostics, Inc.	1992-09-28	124
K922584	BARTELS HERPES SIMPLEX VIRUS 1 IGG EIA	Baxter Diagnostics, Inc.	1992-09-18	114
K923286	STRATUS FOLATE FLUOROMETRIC ENZYME-LINKED ASSAY	Baxter Diagnostics, Inc.	1992-09-17	73
K922586	BARTELS RUBELLA IGG EIA	Baxter Diagnostics, Inc.	1992-09-17	113
K922581	BARTELS RUBELLA IGM EIA	Baxter Diagnostics, Inc.	1992-09-17	113
K922585	BARTELS TOXOPLASMA IGG EIA	Baxter Diagnostics, Inc.	1992-09-02	98
K922331	BARTELS EPSTEIN-BARR VIRUS IGM EIA	Baxter Diagnostics, Inc.	1992-09-02	112

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