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

Cleared Sep 11, 2000

ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST

K001900 · LRM

Immunology · 81d

Cleared Apr 05, 2000

ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST

K000489 · LLL

Immunology · 51d

Cleared May 12, 1998

DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEM

K980337 · LJM

Immunology · 104d

Cleared Mar 20, 1996

ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KIT

K960091 · LRM

Immunology · 69d

Cleared Dec 15, 1995

ENZYME IMMUNOASSAY LUPUS SCREEN TEST KIT

K954700 · LKJ

Immunology · 64d

Cleared Dec 15, 1995

ENZYME IMMUNOASSAY ANA SCREENING TEST KIT

K954723 · LKJ

Immunology · 63d

Cleared Aug 24, 1995

ENZYME IMMUNOASSAY ENA PLUS SCREENING TEST KIT

K952253 · LLL

Immunology · 101d

Cleared Jul 18, 1995

ENZYME IMMUNOASSAY ANTI-JO-1 ANTIBODY TEST KIT

K951850 · LJM

Immunology · 88d

Cleared Jul 17, 1995

ENZYME IMMUNOASSAY ANTI-SCI-70 ANTIBODY TEST KIT

K951798 · LJM

Immunology · 90d

Cleared Apr 20, 1994

ENZYME IMMUNOASSAY ANTI-SM ANTIBODY TEST KIT

K940510 · LKP

Immunology · 75d

Cleared Apr 20, 1994

ENZYME IMMUNOASSAY ANTI-SM/RNP ANTIBODY TEST KIT

K940588 · LKO

Immunology · 71d

Cleared Sep 24, 1993

ENZYME IMMONOASSAY EXTRACTABLE NUCLEAR ANTIGEN

K932850 · LLL

Immunology · 106d

Cleared Aug 05, 1993

ANTI-SS-B/LA ANTIBODY TEST

K932419 · LLL

Immunology · 79d

Cleared Jul 16, 1993

ENZYME IMMUNOASSAY ANTI-SS-A/RO ANTIBODY TEST KIT

K931495 · LLL

Immunology · 113d

Cleared Nov 05, 1991

ANTI-DSDNA ANTIBODY TEST

K913041 · LLL

Immunology · 119d