Helix Diagnostics, Inc. is one of 24537 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Helix Diagnostics, Inc. - FDA 510(k) Cleared Devices
Recent clearances: ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST, ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST, DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEM
15
Total
15
Cleared
0
Denied
Helix Diagnostics, Inc. has 15 FDA 510(k) cleared immunology devices. Based in West Sacramento, US.
Historical record: 15 cleared submissions from 1991 to 2000.
Browse the complete list of FDA 510(k) cleared immunology devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Helix Diagnostics, Inc.
15 devices
Cleared
Sep 11, 2000
ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST
Immunology
81d
Cleared
Apr 05, 2000
ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST
Immunology
51d
Cleared
May 12, 1998
DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEM
Immunology
104d
Cleared
Mar 20, 1996
ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KIT
Immunology
69d
Cleared
Dec 15, 1995
ENZYME IMMUNOASSAY LUPUS SCREEN TEST KIT
Immunology
64d
Cleared
Dec 15, 1995
ENZYME IMMUNOASSAY ANA SCREENING TEST KIT
Immunology
63d
Cleared
Aug 24, 1995
ENZYME IMMUNOASSAY ENA PLUS SCREENING TEST KIT
Immunology
101d
Cleared
Jul 18, 1995
ENZYME IMMUNOASSAY ANTI-JO-1 ANTIBODY TEST KIT
Immunology
88d
Cleared
Jul 17, 1995
ENZYME IMMUNOASSAY ANTI-SCI-70 ANTIBODY TEST KIT
Immunology
90d
Cleared
Apr 20, 1994
ENZYME IMMUNOASSAY ANTI-SM ANTIBODY TEST KIT
Immunology
75d
Cleared
Apr 20, 1994
ENZYME IMMUNOASSAY ANTI-SM/RNP ANTIBODY TEST KIT
Immunology
71d
Cleared
Sep 24, 1993
ENZYME IMMONOASSAY EXTRACTABLE NUCLEAR ANTIGEN
Immunology
106d
Cleared
Aug 05, 1993
ANTI-SS-B/LA ANTIBODY TEST
Immunology
79d
Cleared
Jul 16, 1993
ENZYME IMMUNOASSAY ANTI-SS-A/RO ANTIBODY TEST KIT
Immunology
113d
Cleared
Nov 05, 1991
ANTI-DSDNA ANTIBODY TEST
Immunology
119d