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

J.T. Baker Chemical Co. · Predicate Candidate Screening

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

38 daysmedian FDA review time

85 days90th percentile

54clearances measured

K-number	Device	Applicant	Decided	Review days
K803128	SERIES 810 PLATELET ANALYZER	J.T. Baker Chemical Co.	1981-04-03	112
K802080	BAKER DIAG. ULTRARATE CHLORIDE KIT	J.T. Baker Chemical Co.	1980-10-10	43
K802035	BAKER DIAG. ULTRARATE CO2 REAGENT KIT	J.T. Baker Chemical Co.	1980-09-26	35
K801909	LSA 290 ASSAY REAGENTS/NEPHELOMETRIC	J.T. Baker Chemical Co.	1980-09-26	46
K801669	J.T. BAKER ALPHA-1-ANTITRYPSIN NEPHELO	J.T. Baker Chemical Co.	1980-09-16	56
K801662	J.T. BAKER ALPHA-2-MACROGLOBULIN NEPH.	J.T. Baker Chemical Co.	1980-09-16	57
K801661	J.T. BAKER CERULOPLASMIN NEPHELOMETRIC	J.T. Baker Chemical Co.	1980-09-16	57
K801795	BAKER DIAGNOSTIC ULTRA-RATE SODIUM/POT.	J.T. Baker Chemical Co.	1980-09-16	49
K801362	ALBUMIN NEPHELOMETRIC ASSAY	J.T. Baker Chemical Co.	1980-07-21	42
K801432	HEMOPEXIN NEPHELOMETRIC ASSAY	J.T. Baker Chemical Co.	1980-07-08	20
K801434	J.T. BAKER TRANSFERRIN NEPHELOMETRIC ASS	J.T. Baker Chemical Co.	1980-07-08	20
K801433	HAPTOGLOBIN NEPHELOMETRIC ASSAY	J.T. Baker Chemical Co.	1980-07-08	20
K801361	COMPLEMENT C4 NEPHELOMETRIC ASSAY	J.T. Baker Chemical Co.	1980-06-30	21
K801363	COMPLEMENT C3 NEPHELOMETRIC ASSAY	J.T. Baker Chemical Co.	1980-06-30	21
K801282	J.T. BAKER IMMUNO. M. NEPHELOMETRIC ASSA	J.T. Baker Chemical Co.	1980-06-30	32
K801283	J.T. BAKER IMMUNO. A NEPHELOMETRIC ASSAY	J.T. Baker Chemical Co.	1980-06-30	32
K801281	J.T. BAKER IMMUNOGLOBULIN G NEPHELOMETRI	J.T. Baker Chemical Co.	1980-06-20	22
K801090	J.T. BAKER LSA 290 PIPETTER/DILUTER	J.T. Baker Chemical Co.	1980-06-09	32
K801091	K 750 COMPUTER/DATA PROCESSOR	J.T. Baker Chemical Co.	1980-06-09	32
K801089	J.T. BAKER NEPHELOMETER	J.T. Baker Chemical Co.	1980-05-28	20
K790044	REAGENT KIT, BAKERS DIAGNOSTIC	J.T. Baker Chemical Co.	1979-02-22	48
K790045	REAGENT KIT, CHLORIDE/CARBON DIOXIDE	J.T. Baker Chemical Co.	1979-02-22	48
K781240	ENZYMATIC TRIGLYCERIDES REAGENT KIT	J.T. Baker Chemical Co.	1978-08-17	28
K780783	AUTOZYME CHOLESTEROL-OXIDASE REAGENT KIT	J.T. Baker Chemical Co.	1978-06-06	25
K772308	AUTOZYME GLUCOSE OXIDASE (TRINDER)	J.T. Baker Chemical Co.	1978-03-03	77
K772172	DYNAZYME TM II CARDIAK-MB	J.T. Baker Chemical Co.	1977-12-06	15
K771153	DYNA ZYME II GOT 340	J.T. Baker Chemical Co.	1977-11-03	129
K771152	DYNAZYME II GPT 340	J.T. Baker Chemical Co.	1977-11-03	129
K771790	DETECTOTERGE AZIDE FREE	J.T. Baker Chemical Co.	1977-10-07	17
K771789	BLANKING SOLUTION HGB	J.T. Baker Chemical Co.	1977-10-07	17
K771788	CYMET-AUTOMATED	J.T. Baker Chemical Co.	1977-10-07	17
K771787	AZIDE FREE BLOOD DILUTING REAGENT	J.T. Baker Chemical Co.	1977-10-07	17
K771716	CYMET-PLUS	J.T. Baker Chemical Co.	1977-09-20	8
K771084	DYNAZYME II Y-GT	J.T. Baker Chemical Co.	1977-08-04	49
K771085	DYNAZYME II ALKALINE PHOSPHATASE	J.T. Baker Chemical Co.	1977-08-04	49
K771059	DIAG. OZYRATE GLUCOSE REAG. SET	J.T. Baker Chemical Co.	1977-07-21	38
K771060	DIAG. CONDUCTA RATE BUN REAG. SET	J.T. Baker Chemical Co.	1977-07-21	38
K761304	JTB 700 HEMATOLOGY ANALYZER	J.T. Baker Chemical Co.	1977-02-01	41
K761343	DYNAZYME-II TM LDH-L 340 KIT	J.T. Baker Chemical Co.	1977-01-05	8
K761344	DYNAZYME-II TM CK-230 KIT	J.T. Baker Chemical Co.	1977-01-05	8
K761345	GLUCO-HEX TM REAGENT KIT	J.T. Baker Chemical Co.	1977-01-05	8
K760412	LDH SUBSTRATE	J.T. Baker Chemical Co.	1976-11-02	85
K760408	POTASSIUM SODIUM TARTRATE	J.T. Baker Chemical Co.	1976-11-02	85
K760409	SODIUM NITRITE	J.T. Baker Chemical Co.	1976-11-02	85
K760397	REAGENT, AMP BUFFER DIAGNOSTIC	J.T. Baker Chemical Co.	1976-11-01	87
K760411	NAD (SPOONPAK CONTAINER)	J.T. Baker Chemical Co.	1976-10-29	81
K760398	REAGENT, MAGNESIUM CHLORIDE	J.T. Baker Chemical Co.	1976-10-29	84
K760410	AMP BUFFER	J.T. Baker Chemical Co.	1976-10-29	81
K760407	SULFANILIC ACID	J.T. Baker Chemical Co.	1976-10-29	81
K760406	CAFFEINE DILUENT	J.T. Baker Chemical Co.	1976-10-29	81

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