Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Helix Diagnostics, Inc.

FDA 510(k) & PMA Approved Devices — 15 products

Total Devices15
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K001900 ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TESTLRM2000-09-11 View
510(k) K000489 ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TESTLLL2000-04-05 View
510(k) K980337 DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEMLJM1998-05-12 View
510(k) K960091 ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KITLRM1996-03-20 View
510(k) K954723 ENZYME IMMUNOASSAY ANA SCREENING TEST KITLKJ1995-12-15 View
510(k) K954700 ENZYME IMMUNOASSAY LUPUS SCREEN TEST KITLKJ1995-12-15 View
510(k) K952253 ENZYME IMMUNOASSAY ENA PLUS SCREENING TEST KITLLL1995-08-24 View
510(k) K951850 ENZYME IMMUNOASSAY ANTI-JO-1 ANTIBODY TEST KITLJM1995-07-18 View
510(k) K951798 ENZYME IMMUNOASSAY ANTI-SCI-70 ANTIBODY TEST KITLJM1995-07-17 View
510(k) K940510 ENZYME IMMUNOASSAY ANTI-SM ANTIBODY TEST KITLKP1994-04-20 View
510(k) K940588 ENZYME IMMUNOASSAY ANTI-SM/RNP ANTIBODY TEST KITLKO1994-04-20 View
510(k) K932850 ENZYME IMMONOASSAY EXTRACTABLE NUCLEAR ANTIGENLLL1993-09-24 View
510(k) K932419 ANTI-SS-B/LA ANTIBODY TESTLLL1993-08-05 View
510(k) K931495 ENZYME IMMUNOASSAY ANTI-SS-A/RO ANTIBODY TEST KITLLL1993-07-16 View
510(k) K913041 ANTI-DSDNA ANTIBODY TESTLLL1991-11-05 View
↑