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JTL — Plasma, Coagulase, Human, Horse And Rabbit Class I

FDA Device Classification

Classification Details

Product Code
JTL
Device Class
Class I
Regulation Number
866.2160
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K950706difco laboratoriesDRYSLIDE COAGULASEMay 16, 1995
K883333immuno-mycologicsRABBIT PLASMA FIBRINOGEN (RPF) SUPPLEMENTAugust 25, 1988
K870945oxoid u.s.aRABBIT PLASMA FIBRINOGEN SUPPLEMENT SR 122June 10, 1987
K861312micro-bio-logicsLYFO-KWIK (TM) COAGULASE PLASMAApril 18, 1986
K840553remelHEMASTAPHApril 13, 1984
K833988analytical productsAPI STAPHASE IIIDecember 22, 1983
K833858otisville biotechCOAGULASE PLASMA, HORSE & RABBIT EDTADecember 8, 1983
K822988american scientific productsCOAGULASE PLASMA-CITRATED & EDTANovember 5, 1982
K820177quadromaCOAGULASE PLASMAFebruary 5, 1982
K812602dutchland laboratoriesRABBIT COAGULASE PLASMASeptember 29, 1981
K811982analytical productsSTAPHASE*July 28, 1981
K792235remelCOAGULASE PLASMADecember 7, 1979