FDA 510(k) Applications for Medical Device Product Code "DDX"
(Plasminogen, Antigen, Antiserum, Control)

FDA 510(k) Number Applicant Device Name Decision Date
K884766 BEHRING DIAGNOSTICS, INC. BERICHROM(R) PLASMINOGEN 01/04/1989
K781478 DADE, BAXTER TRAVENOL DIAGNOSTICS, INC. PLASMINOGEN ASSAY 11/15/1978
K812625 E.I. DUPONT DE NEMOURS & CO., INC. ACA PLASMINOGEN TEST PACK 09/29/1981
K811777 HELENA LABORATORIES HELENA PLASMINOGEN QUIPLATE PROCEDURE 07/02/1981
K772085 HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES LAS-R HUMAN PLASMINOGEN TEST 01/24/1978
K864212 INSTRUMENTATION LABORATORY CO. IL TEST 97573-15, PLASMINOGEN ASSAY 12/04/1986
K854572 KABIVITRUM, INC. COATEST PLASMINOGEN 02/26/1986
K941346 THE BINDING SITE, LTD. PLASMINOGEN RID TEST KIT 09/09/1994
K850410 WARNER-LAMBERT CO. GEN. DIAG. CHROMOSTRATE PLASMINOGEN ASSAY 05/08/1985
K832591 WELLCOME DIAGNOSTICS DIACROM *PLG 11/21/1983


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