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Dade, Baxter Travenol Diagnostics, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
44
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K800296WHOLE BLOOD GAS CONTROL, LEVELS 1,2,&3March 5, 1980
K792606WHOLE BLOOD PLATELET CONTROL NORMAL,February 13, 1980
K792723BLOOD FLUID FILTERSJanuary 21, 1980
K792607T3 UPTAKE (T3U) REAGENTSJanuary 16, 1980
K792443TSH RADIOIMMUNOASSAYDecember 27, 1979
K792442FERRITIN RADIOIMMUNOASSAYDecember 18, 1979
K791922HARLECO BRAND CLINICARD LIPASE TEST SETNovember 27, 1979
K792183DADE HIGH DENSITY LIPOPROTEIN CHOLESTERONovember 13, 1979
K790767IMMU-TEK AUTOMATIC CENTRIFUGEMay 23, 1979
K790776DADE LOW IONIC STRENGTH SOLUITION (LISS)May 23, 1979
K790571QUIK-STAINApril 23, 1979
K790264DATA-TOPE TRI-RAC RADIOASSAY CONTROLMarch 21, 1979
K790204PLASMA, STANDARDIZED NORMALMarch 12, 1979
K781479HEPARIN ASSAYFebruary 15, 1979
K782150FLUROMETER, DADEFebruary 15, 1979
K782098REAGENT, LYSING AND HEMOGLOBINJanuary 17, 1979
K781478PLASMINOGEN ASSAYNovember 15, 1978
K781480ANTITHROMBIN III ASSAYNovember 8, 1978
K781593RIA CONTROLSOctober 17, 1978
K781077CONTROL, HEMATOLOGY, CH-60July 27, 1978