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DDX — Plasminogen, Antigen, Antiserum, Control Class I

FDA Device Classification

Classification Details

Product Code
DDX
Device Class
Class I
Regulation Number
866.5715
Submission Type
Review Panel
HE
Medical Specialty
Immunology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K941346binding sitePLASMINOGEN RID TEST KITSeptember 9, 1994
K884766behring diagnosticsBERICHROM(R) PLASMINOGENJanuary 4, 1989
K864212instrumentation laboratoryIL TEST 97573-15, PLASMINOGEN ASSAYDecember 4, 1986
K854572kabivitrumCOATEST PLASMINOGENFebruary 26, 1986
K850410warner-lambertGEN. DIAG. CHROMOSTRATE PLASMINOGEN ASSAYMay 8, 1985
K832591wellcome diagnosticsDIACROM *PLGNovember 21, 1983
K812625e.i. dupont de nemours and coACA PLASMINOGEN TEST PACKSeptember 29, 1981
K811777helena laboratoriesHELENA PLASMINOGEN QUIPLATE PROCEDUREJuly 2, 1981
K781478dade, baxter travenol diagnosticsPLASMINOGEN ASSAYNovember 15, 1978
K772085hyland therapeutic div., travenol laboratoriesLAS-R HUMAN PLASMINOGEN TESTJanuary 24, 1978