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Shield Diagnostics, Ltd.

FDA 510(k) & PMA Approved Devices — 27 products

Total Devices27
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K000398 SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200GGP2000-04-17 View
510(k) K982879 SHIELD DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGG (ELISA) ASSAYMSV1998-10-15 View
510(k) K980885 SHIELD ACTIVATED FACTOR XII (ELISA) ASSAYGGP1998-08-21 View
510(k) K972981 SHIELD HELICO-G2 ELISA KITLYR1998-03-17 View
510(k) K962825 SHIELD VON WILLEBRAND FACTOR ACTIVITY (ELISA) ASSAYGGP1996-11-15 View
510(k) K963525 DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KITDBL1996-11-07 View
510(k) K961515 QUANTASE PHENYLALANINE ASSAYJNB1996-06-12 View
510(k) K955303 DIASTAT ANTI-CARDIOLIPIN KITMID1996-05-30 View
510(k) K952183 DIASTAT ANTI-THYROGLOBULIN KITJZO1995-06-30 View
510(k) K951487 DIASTAT ANTI-THYROID PEROXIDASE KITJZO1995-06-30 View
510(k) K942813 DIASTAT ANTI-PR3 (C-ANCA) KITMOB1995-03-06 View
510(k) K943630 DIASTAT ANTI-MPO (PANCA) KITMOB1995-03-06 View
510(k) K944505 DIASTAT ENA SINGLE WELL SCREEN KITLLL1994-11-21 View
510(k) K932876 DIASTAT ANTI-NUCLEAR ANTIBODY (ANA) KITLKJ1993-11-15 View
510(k) K932877 DIASTAT ANTI-CENTROMERE KITLLL1993-10-15 View
510(k) K923886 DIASTAT TOTAL ANTI-CARDIOLIPIN KITMID1992-09-25 View
510(k) K921265 DIASTAT ANTI-CARDIOLIPIN KITMID1992-08-03 View
510(k) K920616 DIASTAT ANTI-HISTONE KITLJM1992-07-14 View
510(k) K921183 DIASTAT ANTI-MITOCHONDRIAL ANTIBODY KITDBM1992-06-19 View
510(k) K912292 DIASTAT ANTI-JO-1 KITDHN1991-07-30 View
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