Medical Device Manufacturer · KN , Scotland

Shield Diagnostics, Ltd.

27 submissions · 27 cleared · Since 1990
27
Total
27
Cleared
0
Denied

Shield Diagnostics, Ltd. — FDA 510(k) Submissions

Shield Diagnostics, Ltd. has submitted 27 FDA 510(k) premarket notifications since 1990, of which 27 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Test, Anticardiolipin Immunological, Test, Qualitative And Quantitative Factor Deficiency, Antinuclear Antibody, Antigen, Control, Extractable Antinuclear Antibody, Antigen And Control, Test System, Antineutrophil Cytoplasmic Antibodies (anca) . Use the specialty filter in the sidebar to narrow results.

27 devices
1–25 of 27
SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200
K000398 · GGP Test, Qualitative And... · Hematology
Apr 2000 70d
SHIELD DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGG (ELISA) ASSAY
K982879 · MSV System,test,antibodies,b2... · Immunology
Oct 1998 62d
SHIELD ACTIVATED FACTOR XII (ELISA) ASSAY
K980885 · GGP Test, Qualitative And... · Hematology
Aug 1998 165d
SHIELD HELICO-G2 ELISA KIT
K972981 · LYR Helicobacter Pylori · Microbiology
Mar 1998 218d
SHIELD VON WILLEBRAND FACTOR ACTIVITY (ELISA) ASSAY
K962825 · GGP Test, Qualitative And... · Hematology
Nov 1996 119d
DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT
K963525 · DBL Multiple Autoantibodies,... · Immunology
Nov 1996 64d
QUANTASE PHENYLALANINE ASSAY
K961515 · JNB Ninhydrin And... · Chemistry
Jun 1996 63d
DIASTAT ANTI-CARDIOLIPIN KIT
K955303 · MID System, Test,... · Immunology
May 1996 192d
DIASTAT ANTI-THYROID PEROXIDASE KIT
K951487 · JZO System, Test, Thyroid... · Immunology
Jun 1995 91d
DIASTAT ANTI-THYROGLOBULIN KIT
K952183 · JZO System, Test, Thyroid... · Immunology
Jun 1995 52d
DIASTAT ANTI-PR3 (C-ANCA) KIT
K942813 · MOB Test System,... · Immunology
Mar 1995 265d
DIASTAT ANTI-MPO (PANCA) KIT
K943630 · MOB Test System,... · Immunology
Mar 1995 223d
DIASTAT ENA SINGLE WELL SCREEN KIT
K944505 · LLL Extractable Antinuclear... · Immunology
Nov 1994 68d
DIASTAT ANTI-NUCLEAR ANTIBODY (ANA) KIT
K932876 · LKJ Antinuclear Antibody,... · Immunology
Nov 1993 154d
DIASTAT ANTI-CENTROMERE KIT
K932877 · LLL Extractable Antinuclear... · Immunology
Oct 1993 123d
DIASTAT TOTAL ANTI-CARDIOLIPIN KIT
K923886 · MID System, Test,... · Immunology
Sep 1992 52d
DIASTAT ANTI-CARDIOLIPIN KIT
K921265 · MID System, Test,... · Immunology
Aug 1992 140d
DIASTAT ANTI-HISTONE KIT
K920616 · LJM Antinuclear Antibody... · Immunology
Jul 1992 154d
DIASTAT ANTI-MITOCHONDRIAL ANTIBODY KIT
K921183 · DBM Antimitochondrial... · Immunology
Jun 1992 102d
DISTAT ANTI-SCL-70 KIT
K912291 · LKJ Antinuclear Antibody,... · Immunology
Jul 1991 68d
DIASTAT ANTI-JO-1 KIT
K912292 · DHN Antinuclear Antibody,... · Immunology
Jul 1991 68d
DIASTAT ANTI-LA (SS-B)
K905193 · LKO Anti-rnp Antibody,... · Immunology
Dec 1990 24d
DIASTAT ANTI-RO (SS-A)
K905194 · LKO Anti-rnp Antibody,... · Immunology
Dec 1990 24d
DISTAT ANTI-DSDNA KIT
K905386 · KTL Anti-dna Indirect... · Immunology
Dec 1990 13d
DIASTAT ENA PROFILE
K905190 · LJM Antinuclear Antibody... · Immunology
Dec 1990 18d
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