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Dade Intl., Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
30
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K974343DADE INNOVINJuly 22, 1998
K970505DADE PFA-100 PLATELET FUNCTION ANALYZER/PFA COLLAGEN/EPINEPHRINE TEST CARTRIDGE/PFA COLLAGEN/ADP TESNovember 17, 1997
K973974DADE TRU-LIQUID CARDIAC CONTROLNovember 6, 1997
K973668CARDIAC TROPONIN-I (TROP) CALIBRATOROctober 20, 1997
K972524DRIED GRAM-POSITIVE MIC/COMBO PANELSSeptember 8, 1997
K972782DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAYAugust 15, 1997
K972287DADE TRU-LIQUID BILIRUBIN CONTROLJuly 7, 1997
K964660PARAMAX CHOLESTEROL REAGENTJune 4, 1997
K970676DRIED GRAM-NEGATIVE MIC/COMBO PANELSMay 2, 1997
K964715PARAMAX SALICYLATE REAGENTApril 25, 1997
K970330DADE INDIRECT IMT SYSTEM WITH TCO2 ELECTRODEApril 14, 1997
K964346PARAMAX TRIGLYCERID REAGENTMarch 28, 1997
K964862TROPONIN-I TEST SYSTEMFebruary 10, 1997
K965213STRATUS MYOGLOBIN GLUOROMETRIC ENZYME IMMUNOASSAYFebruary 10, 1997
K964139SYSMEX CA-6000February 6, 1997
K964565PARAMAX AMMONIA AND AMMONIA BLANK REAGENTNovember 22, 1996
K963244ACETAMINOPHEN FLEX REAGENT CARTRIDGESeptember 23, 1996
K962817DRUG CALIBRATOR IISeptember 16, 1996
K962820CARBAMAZEPINE FLEX REAGENT CARTRIDGESeptember 13, 1996
K962818TOBRAMYCIN FLEX REAGENT CARTRIDGESeptember 13, 1996