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FDA 510(k) & PMA Approved Devices — 13 products

Total Devices13
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K941752 SPECTROLYSE ANTIPLASMIN KITGGP1995-09-25 View
510(k) K942087 BIOPOOL VWF ELD KIT AND VWF ELD BULK PLATESGGP1995-07-13 View
510(k) K934314 TINTELIZER(R) TPAGGP1994-02-23 View
510(k) K923499 SPECTROLYSE HEPARIN KITKFF1994-01-27 View
510(k) K932463 BIOCLOT LAGIR1993-09-27 View
510(k) K920668 MINUTEX D-DIMER LATEX TESTGHH1992-10-16 View
510(k) K922782 SPECTROLYSE/PL PAI KITGGP1992-10-09 View
510(k) K915163 PROTEIN S EID KIT AND PROTEIN S EID BULK PLATESGGP1992-01-06 View
510(k) K914307 SPECTROLYSE PROTEIN C KITGGP1991-12-09 View
510(k) K912025 SPECTROLYSE PLASMINOGEN SK KITGGP1991-08-22 View
510(k) K902566 BIOPOOL PROTEIN C EID KIT AND BULK PLATESGGP1990-08-09 View
510(k) K902530 SPECTROLYSE ATIII KITJBQ1990-08-09 View
510(k) K902528 BIOCLOT C KITGGP1990-08-09 View
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