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Shield Diagnostics, Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
27
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K000398SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200April 17, 2000
K982879SHIELD DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGG (ELISA) ASSAYOctober 15, 1998
K980885SHIELD ACTIVATED FACTOR XII (ELISA) ASSAYAugust 21, 1998
K972981SHIELD HELICO-G2 ELISA KITMarch 17, 1998
K962825SHIELD VON WILLEBRAND FACTOR ACTIVITY (ELISA) ASSAYNovember 15, 1996
K963525DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KITNovember 7, 1996
K961515QUANTASE PHENYLALANINE ASSAYJune 12, 1996
K955303DIASTAT ANTI-CARDIOLIPIN KITMay 30, 1996
K952183DIASTAT ANTI-THYROGLOBULIN KITJune 30, 1995
K951487DIASTAT ANTI-THYROID PEROXIDASE KITJune 30, 1995
K942813DIASTAT ANTI-PR3 (C-ANCA) KITMarch 6, 1995
K943630DIASTAT ANTI-MPO (PANCA) KITMarch 6, 1995
K944505DIASTAT ENA SINGLE WELL SCREEN KITNovember 21, 1994
K932876DIASTAT ANTI-NUCLEAR ANTIBODY (ANA) KITNovember 15, 1993
K932877DIASTAT ANTI-CENTROMERE KITOctober 15, 1993
K923886DIASTAT TOTAL ANTI-CARDIOLIPIN KITSeptember 25, 1992
K921265DIASTAT ANTI-CARDIOLIPIN KITAugust 3, 1992
K920616DIASTAT ANTI-HISTONE KITJuly 14, 1992
K921183DIASTAT ANTI-MITOCHONDRIAL ANTIBODY KITJune 19, 1992
K912292DIASTAT ANTI-JO-1 KITJuly 30, 1991