Shield Diagnostics, Ltd. - FDA 510(k) Cleared Devices

Cleared Oct 15, 1998

SHIELD DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGG (ELISA) ASSAY

K982879 · MSV

Immunology · 62d

Cleared Nov 07, 1996

DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT

K963525 · DBL

Immunology · 64d

Cleared May 30, 1996

DIASTAT ANTI-CARDIOLIPIN KIT

K955303 · MID

Immunology · 192d

Cleared Jun 30, 1995

DIASTAT ANTI-THYROID PEROXIDASE KIT

K951487 · JZO

Immunology · 91d

Cleared Jun 30, 1995

DIASTAT ANTI-THYROGLOBULIN KIT

K952183 · JZO

Immunology · 52d

Cleared Mar 06, 1995

DIASTAT ANTI-PR3 (C-ANCA) KIT

K942813 · MOB

Immunology · 265d

Cleared Mar 06, 1995

DIASTAT ANTI-MPO (PANCA) KIT

K943630 · MOB

Immunology · 223d

Cleared Nov 21, 1994

DIASTAT ENA SINGLE WELL SCREEN KIT

K944505 · LLL

Immunology · 68d

Cleared Nov 15, 1993

DIASTAT ANTI-NUCLEAR ANTIBODY (ANA) KIT

K932876 · LKJ

Immunology · 154d

Cleared Oct 15, 1993

DIASTAT ANTI-CENTROMERE KIT

K932877 · LLL

Immunology · 123d

Cleared Sep 25, 1992

DIASTAT TOTAL ANTI-CARDIOLIPIN KIT

K923886 · MID

Immunology · 52d

Cleared Aug 03, 1992

DIASTAT ANTI-CARDIOLIPIN KIT

K921265 · MID

Immunology · 140d

Cleared Jul 14, 1992

DIASTAT ANTI-HISTONE KIT

K920616 · LJM

Immunology · 154d

Cleared Jun 19, 1992

DIASTAT ANTI-MITOCHONDRIAL ANTIBODY KIT

K921183 · DBM

Immunology · 102d

Cleared Jul 30, 1991

DISTAT ANTI-SCL-70 KIT

K912291 · LKJ

Immunology · 68d

Cleared Jul 30, 1991

DIASTAT ANTI-JO-1 KIT

K912292 · DHN

Immunology · 68d

Cleared Dec 13, 1990

DIASTAT ANTI-LA (SS-B)

K905193 · LKO

Immunology · 24d

Cleared Dec 13, 1990

DIASTAT ANTI-RO (SS-A)

K905194 · LKO

Immunology · 24d

Cleared Dec 13, 1990

DISTAT ANTI-DSDNA KIT

K905386 · KTL

Immunology · 13d

Cleared Dec 07, 1990

DIASTAT ENA PROFILE

K905190 · LJM

Immunology · 18d

Cleared Dec 07, 1990

DIASTAT ANTI-SM

K905191 · LKP

Immunology · 18d

Cleared Dec 07, 1990

DIASTAT ANTI-SM/RNP

K905192 · LKP

Immunology · 18d