510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Dade, Baxter Travenol Diagnostics, Inc.

Mchenry, IL, US

Dade, Baxter Travenol Diagnostics, Inc. appears in FDA device records in Mchenry, IL. FDA records list 44 510(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
44
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 44 510(k) clearances for Dade, Baxter Travenol Diagnostics, Inc. between 1976 and 1980. The busiest year on record is 1977, with 13. The most recent is 1980, with 4.

Clearances by year, as a table
510(k) clearance decisions for Dade, Baxter Travenol Diagnostics, Inc., by decision year
YearClearances
19767
197713
19788
197912
19804
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K800296WHOLE BLOOD GAS CONTROL, LEVELS 1,2,&3GGMSubstantially Equivalent
K792606WHOLE BLOOD PLATELET CONTROL NORMAL,JPKSubstantially Equivalent
K792723BLOOD FLUID FILTERSJKASubstantially Equivalent
K792607T3 UPTAKE (T3U) REAGENTSKHQSubstantially Equivalent
K792443TSH RADIOIMMUNOASSAYJLWSubstantially Equivalent
K792442FERRITIN RADIOIMMUNOASSAYDBFSubstantially Equivalent
K791922HARLECO BRAND CLINICARD LIPASE TEST SETCETSubstantially Equivalent
K792183DADE HIGH DENSITY LIPOPROTEIN CHOLESTEROLBSSubstantially Equivalent
K790776DADE LOW IONIC STRENGTH SOLUITION (LISS)KSGSubstantially Equivalent
K790767IMMU-TEK AUTOMATIC CENTRIFUGEKSNSubstantially Equivalent
K790571QUIK-STAINIAFSubstantially Equivalent
K790264DATA-TOPE TRI-RAC RADIOASSAY CONTROLJJYSubstantially Equivalent
K790204PLASMA, STANDARDIZED NORMALJPASubstantially Equivalent
K782150FLUROMETER, DADEJZTSubstantially Equivalent
K781479HEPARIN ASSAYKFFSubstantially Equivalent
K782098REAGENT, LYSING AND HEMOGLOBINGGKSubstantially Equivalent
K781478PLASMINOGEN ASSAYDDXSubstantially Equivalent
K781480ANTITHROMBIN III ASSAYJBQSubstantially Equivalent
K781593RIA CONTROLSJJYSubstantially Equivalent
K781077CONTROL, HEMATOLOGY, CH-60JPKSubstantially Equivalent
K780801ISOZYME - ID CPK MARKERJJTSubstantially Equivalent
K780208ASPIRATOR, MANUELJQWSubstantially Equivalent
K780281IMMUFUGE DISP. LINERKSOSubstantially Equivalent
K780047PLATELET AGGREGATING REAGENTSJOZSubstantially Equivalent
K771740CARDIOZYME CK-CONTROL LEVEL 1JJTSubstantially Equivalent
K770974CARDIOZYME CK-MB REAGENTSSubstantially Equivalent
K771588PLATELET CONTROLS NORMAL & ABNORMALGJPSubstantially Equivalent
K771346CI-TROL COAGULATION CONTROLS II & IIIGGNSubstantially Equivalent
K771138PIPETS BOROSILICATE GLASSGJWSubstantially Equivalent
K771137PIPETS UNIFORM DROP SIZE BOROSILICATEGJWSubstantially Equivalent
K770973CARDIOZYME CK CONTROL NORMALJJTSubstantially Equivalent
K770971CARDIOZYME CK-CONTROL ABNORMALJJTSubstantially Equivalent
K770950WHOLE BLOOD GAS CONTROLJJSSubstantially Equivalent
K770972CARDIOZYME CK-TOTAL REAGENTSSubstantially Equivalent
K761283TRI-CON TRIGLYCERIDGE REAGENTSJGYSubstantially Equivalent
K761281DATA-TOPE T3 UPTAKE PROCEDUREKHQSubstantially Equivalent
K761284UNIVAL CONTROL CELLSKSFSubstantially Equivalent
K761303IMMU-SAL IMMUNOHEMATOLOGICAL SALINEKSSSubstantially Equivalent
K761282DATA-TOPE T4 RIA PROCEDURECDXSubstantially Equivalent
K760594AUTO-FI COAGULATION INSTRUMENTJPASubstantially Equivalent
K760719UNIFORM DROP SIZE PASTEUR TYPE PIPETSGJGSubstantially Equivalent
K760549PLATELET CONTROLS, NORMAL & ABNORMALJPKSubstantially Equivalent
K760416DATA-TOPE SYSTEM DIGOXIN RIADOGSubstantially Equivalent
K760318ACTIN, ACTIVATED CEPHALOPLASTIN REAGENTGFOSubstantially 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