FDA 510(k) Applications Submitted by VIRGINIA CAPPEL

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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