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Helix Diagnostics, Inc.

15 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST (K001900)Helix Diagnostics, Inc.2000-09-11
ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST (K000489)Helix Diagnostics, Inc.2000-04-05
DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEM (K980337)Helix Diagnostics, Inc.1998-05-12
ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KIT (K960091)Helix Diagnostics, Inc.1996-03-20
ENZYME IMMUNOASSAY ANA SCREENING TEST KIT (K954723)Helix Diagnostics, Inc.1995-12-15
ENZYME IMMUNOASSAY LUPUS SCREEN TEST KIT (K954700)Helix Diagnostics, Inc.1995-12-15
ENZYME IMMUNOASSAY ENA PLUS SCREENING TEST KIT (K952253)Helix Diagnostics, Inc.1995-08-24
ENZYME IMMUNOASSAY ANTI-JO-1 ANTIBODY TEST KIT (K951850)Helix Diagnostics, Inc.1995-07-18
ENZYME IMMUNOASSAY ANTI-SCI-70 ANTIBODY TEST KIT (K951798)Helix Diagnostics, Inc.1995-07-17
ENZYME IMMUNOASSAY ANTI-SM ANTIBODY TEST KIT (K940510)Helix Diagnostics, Inc.1994-04-20
ENZYME IMMUNOASSAY ANTI-SM/RNP ANTIBODY TEST KIT (K940588)Helix Diagnostics, Inc.1994-04-20
ENZYME IMMONOASSAY EXTRACTABLE NUCLEAR ANTIGEN (K932850)Helix Diagnostics, Inc.1993-09-24
ANTI-SS-B/LA ANTIBODY TEST (K932419)Helix Diagnostics, Inc.1993-08-05
ENZYME IMMUNOASSAY ANTI-SS-A/RO ANTIBODY TEST KIT (K931495)Helix Diagnostics, Inc.1993-07-16
ANTI-DSDNA ANTIBODY TEST (K913041)Helix Diagnostics, Inc.1991-11-05

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Every clearance here is in the API, with alerts when new ones post.