Immco Diagnostics, Inc. - FDA 510(k) Cleared Devices

Cleared Sep 09, 2003

IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGM ELISA

K030702 · MSV

Immunology · 187d

Cleared Oct 15, 1999

ANTI-TISSUE TRANSGLUTAMINASE (TTG)ANTIBODY TEST

K992878 · MVM

Immunology · 50d

Cleared Nov 30, 1998

IMMUGLO ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY (ANCA) TEST SYTEM

K982898 · MOB

Immunology · 105d

Cleared Jun 11, 1997

ANTI-CARDIOLIPIN ANTIBODY (ACA) SCREEN ELISA

K970177 · MID

Immunology · 145d

Cleared May 30, 1997

IGA ANTI-GLIADIN (IGA-AGA) ANTIBODY TEST KIT

K964341 · MST

Immunology · 211d

Cleared May 30, 1997

IGG ANTI-GLIADIN (IGG-AGA) ANTIBODY TEST KIT

K964344 · MST

Immunology · 211d

Cleared Jun 20, 1996

THYROID PEROXIDASE ANTIBODY ELISA

K960369 · JZO

Immunology · 147d

Cleared Jun 20, 1996

THYROGLOBULIN ANTIBODY ELISA

K960370 · JZO

Immunology · 147d

Cleared Mar 07, 1995

ANTI-CARDIOLIPIN ANTIBODY (IGA-ACA)TEST)

K933784 · MID

Immunology · 580d

Cleared Mar 07, 1995

ANTI-CARDIOLIPIN ANTIBODY (IGG-ACA) TEST

K933786 · MID

Immunology · 580d

Cleared Mar 07, 1995

ANTI-CARDIOLIPIN ANTIBODY (IGM-ACA) TEST

K933788 · MID

Immunology · 580d

Cleared Jan 20, 1995

ANTI-HISTONE ANIBODY TEST

K943585 · LJM

Immunology · 182d

Cleared Sep 26, 1994

ANTI-RETICULIN ANTIBODY (ARA) TEST

K913360 · DBL

Immunology · 1155d

Cleared Sep 26, 1994

IGM RHEUMATOID FACTOR

K942272 · DHR

Immunology · 139d

Cleared Jun 09, 1993

ANTI-ENDOMYSIAL ANTIBODY TEST

K912551 · DBL

Immunology · 729d

Cleared Mar 22, 1993

ANTI-DSDNA ANTIBODY TEST

K921658 · LSW

Immunology · 349d

Cleared Mar 30, 1992

ANTI-ENA ANTIBODY TEST [SS-A (RO)]

K920383 · LLL

Immunology · 60d

Cleared Mar 30, 1992

ANIT-ENA ANTIBODY TEST [SS-B (LA)]

K920384 · LLL

Immunology · 60d

Cleared Mar 30, 1992

ANTI-ENA ANTIBODY TEST (SM)

K920385 · LLL

Immunology · 60d

Cleared Mar 30, 1992

ANTI-ENA ANTIBODY TEST KIT

K920386 · LLL

Immunology · 60d

Cleared Jan 25, 1991

LUPUS(LE)-LATEX TEST

K905531 · LKI

Immunology · 46d

Cleared Aug 14, 1990

ANTI-SCI-70 ANTIBODY TEST

K903314 · LLL

Immunology · 21d

Cleared Oct 17, 1989

ANTI-RNP AND ANTI-SM ANTIBODY TEST

K895338 · LKO

Immunology · 47d

Cleared Oct 04, 1989

ANTI-SS-A (RO) AND ANTI-SS-B (LA) ANTIBODY TEST

K895339 · LLL

Immunology · 34d

Cleared Mar 22, 1989

ANTI-SKIN ANTIBODY TEST(MONKEY ESOPHAGUS SECTIONS)

K891098 · DBL

Immunology · 20d