510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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J.T. Baker Chemical Co.

Mchenry, IL, US

J.T. Baker Chemical Co. appears in FDA device records in Mchenry, IL. FDA records list 54 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
54
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

Showing 50 of 54

FDA records hold 54 510(k) clearances for J.T. Baker Chemical Co. between 1976 and 1981. The busiest year on record is 1980, with 19. The most recent is 1981, with 1.

Clearances by year, as a table
510(k) clearance decisions for J.T. Baker Chemical Co., by decision year
YearClearances
197613
197716
19783
19792
198019
19811
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K803128SERIES 810 PLATELET ANALYZERGKLSubstantially Equivalent
K802080BAKER DIAG. ULTRARATE CHLORIDE KITJFSSubstantially Equivalent
K802035BAKER DIAG. ULTRARATE CO2 REAGENT KITJFLSubstantially Equivalent
K801909LSA 290 ASSAY REAGENTS/NEPHELOMETRICDEXSubstantially Equivalent
K801795BAKER DIAGNOSTIC ULTRA-RATE SODIUM/POT.JGSSubstantially Equivalent
K801669J.T. BAKER ALPHA-1-ANTITRYPSIN NEPHELODEMSubstantially Equivalent
K801662J.T. BAKER ALPHA-2-MACROGLOBULIN NEPH.DEPSubstantially Equivalent
K801661J.T. BAKER CERULOPLASMIN NEPHELOMETRICDDBSubstantially Equivalent
K801362ALBUMIN NEPHELOMETRIC ASSAYJQXSubstantially Equivalent
K801434J.T. BAKER TRANSFERRIN NEPHELOMETRIC ASSDDGSubstantially Equivalent
K801433HAPTOGLOBIN NEPHELOMETRIC ASSAYDADSubstantially Equivalent
K801432HEMOPEXIN NEPHELOMETRIC ASSAYCZXSubstantially Equivalent
K801363COMPLEMENT C3 NEPHELOMETRIC ASSAYCZWSubstantially Equivalent
K801361COMPLEMENT C4 NEPHELOMETRIC ASSAYDBISubstantially Equivalent
K801283J.T. BAKER IMMUNO. A NEPHELOMETRIC ASSAYCZPSubstantially Equivalent
K801282J.T. BAKER IMMUNO. M. NEPHELOMETRIC ASSADFTSubstantially Equivalent
K801281J.T. BAKER IMMUNOGLOBULIN G NEPHELOMETRIDEWSubstantially Equivalent
K801091K 750 COMPUTER/DATA PROCESSORJQPSubstantially Equivalent
K801090J.T. BAKER LSA 290 PIPETTER/DILUTERJQWSubstantially Equivalent
K801089J.T. BAKER NEPHELOMETERJQXSubstantially Equivalent
K790045REAGENT KIT, CHLORIDE/CARBON DIOXIDEJFSSubstantially Equivalent
K790044REAGENT KIT, BAKERS DIAGNOSTICCGXSubstantially Equivalent
K781240ENZYMATIC TRIGLYCERIDES REAGENT KITCDTSubstantially Equivalent
K780783AUTOZYME CHOLESTEROL-OXIDASE REAGENT KITCHHSubstantially Equivalent
K772308AUTOZYME GLUCOSE OXIDASE (TRINDER)CGASubstantially Equivalent
K772172DYNAZYME TM II CARDIAK-MBJHWSubstantially Equivalent
K771153DYNA ZYME II GOT 340CITSubstantially Equivalent
K771152DYNAZYME II GPT 340CKASubstantially Equivalent
K771790DETECTOTERGE AZIDE FREEGKLSubstantially Equivalent
K771789BLANKING SOLUTION HGBGKRSubstantially Equivalent
K771788CYMET-AUTOMATEDGGKSubstantially Equivalent
K771787AZIDE FREE BLOOD DILUTING REAGENTGIFSubstantially Equivalent
K771716CYMET-PLUSGKKSubstantially Equivalent
K771085DYNAZYME II ALKALINE PHOSPHATASECJESubstantially Equivalent
K771084DYNAZYME II Y-GTSubstantially Equivalent
K771060DIAG. CONDUCTA RATE BUN REAG. SETCDSSubstantially Equivalent
K771059DIAG. OZYRATE GLUCOSE REAG. SETCGASubstantially Equivalent
K761304JTB 700 HEMATOLOGY ANALYZERJPJSubstantially Equivalent
K761345GLUCO-HEX TM REAGENT KITCFRSubstantially Equivalent
K761344DYNAZYME-II TM CK-230 KITCGSSubstantially Equivalent
K761343DYNAZYME-II TM LDH-L 340 KITCFJSubstantially Equivalent
K760412LDH SUBSTRATECFJSubstantially Equivalent
K760409SODIUM NITRITECIGSubstantially Equivalent
K760408POTASSIUM SODIUM TARTRATECIGSubstantially Equivalent
K760397REAGENT, AMP BUFFER DIAGNOSTICCJESubstantially Equivalent
K760411NAD (SPOONPAK CONTAINER)CFJSubstantially Equivalent
K760410AMP BUFFERCFJSubstantially Equivalent
K760407SULFANILIC ACIDCIGSubstantially Equivalent
K760406CAFFEINE DILUENTCIGSubstantially Equivalent
K760398REAGENT, MAGNESIUM CHLORIDECJESubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain