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Dade Intl., Inc.

FDA 510(k) & PMA Approved Devices — 30 products

Total Devices30
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K974343 DADE INNOVINGJS1998-07-22 View
510(k) K970505 DADE PFA-100 PLATELET FUNCTION ANALYZER/PFA COLLAGEN/EPINEPHRINE TEST CARTRIDGE/PFA COLLAGEN/ADP TEST CARTRIDGE/JOZ1997-11-17 View
510(k) K973974 DADE TRU-LIQUID CARDIAC CONTROLJJT1997-11-06 View
510(k) K973668 CARDIAC TROPONIN-I (TROP) CALIBRATORJIT1997-10-20 View
510(k) K972524 DRIED GRAM-POSITIVE MIC/COMBO PANELSJWY1997-09-08 View
510(k) K972782 DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAYJHX1997-08-15 View
510(k) K972287 DADE TRU-LIQUID BILIRUBIN CONTROLJJX1997-07-07 View
510(k) K964660 PARAMAX CHOLESTEROL REAGENTCHH1997-06-04 View
510(k) K970676 DRIED GRAM-NEGATIVE MIC/COMBO PANELSJWY1997-05-02 View
510(k) K964715 PARAMAX SALICYLATE REAGENTDKJ1997-04-25 View
510(k) K970330 DADE INDIRECT IMT SYSTEM WITH TCO2 ELECTRODECEM1997-04-14 View
510(k) K964346 PARAMAX TRIGLYCERID REAGENTCDT1997-03-28 View
510(k) K965213 STRATUS MYOGLOBIN GLUOROMETRIC ENZYME IMMUNOASSAYDDR1997-02-10 View
510(k) K964862 TROPONIN-I TEST SYSTEMMMI1997-02-10 View
510(k) K964139 SYSMEX CA-6000GKP1997-02-06 View
510(k) K964565 PARAMAX AMMONIA AND AMMONIA BLANK REAGENTJIF1996-11-22 View
510(k) K963244 ACETAMINOPHEN FLEX REAGENT CARTRIDGELDP1996-09-23 View
510(k) K962817 DRUG CALIBRATOR IIDKB1996-09-16 View
510(k) K962819 GENTAMICIN FLEX REAGENT CARTRIDGELCD1996-09-13 View
510(k) K962820 CARBAMAZEPINE FLEX REAGENT CARTRIDGEKLT1996-09-13 View
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