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LGP — Assay, Alpha-2-Antiplasmin Class II

FDA Device Classification

Classification Details

Product Code
LGP
Device Class
Class II
Regulation Number
864.5425
Submission Type
Review Panel
HE
Medical Specialty
Hematology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K864213instrumentation laboratoryIL TEST 97572-15, ALPHA 2-ANTIPLASMIN ASSAYNovember 25, 1986
K850411warner-lambertGEN. DIAG. CHROMOSTRATE ALPHA-2 ANTIPLASMIN ASSAYMay 8, 1985
K833890kabivitrumCOATEST ANTIPLASMINJanuary 30, 1984
K803110american dadePROTEOLYTIC ENZYME CONTROLFebruary 17, 1981
K802840american dadeALPHA-ANTIPLASM ASSAYFebruary 17, 1981