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FDA 510(k) Applications Submitted by HELIX DIAGNOSTICS, INC.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K000489
02/14/2000
ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST
HELIX DIAGNOSTICS, INC.
K001900
06/22/2000
ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST
HELIX DIAGNOSTICS, INC.
K960091
01/11/1996
ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KIT
HELIX DIAGNOSTICS, INC.
K980337
01/28/1998
DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEM
HELIX DIAGNOSTICS, INC.
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