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JCO — Bothrops Atrox Reagent Class II

FDA Device Classification

Classification Details

Product Code
JCO
Device Class
Class II
Regulation Number
864.8100
Submission Type
Review Panel
HE
Medical Specialty
Hematology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K955115medical diagnostic technologiesVENOM TIEM REAGENTApril 3, 1996
K932787behring diagnosticsBATROXOBIN REAGENTNovember 29, 1993
K896033medical diagnostic technologiesFDP COLLECTION TUBESOctober 27, 1989
K852519e.i. dupont de nemours and coDUPONT ACA FIBRIN DEGRADATION PROD CLOTTING TUBEAugust 12, 1985
K843207bio/dataREPTILASE -PCOctober 23, 1984
K840210wellcome diagnosticsREPTILASE-R HA35April 23, 1984
K780355sigma chemicalATROXINApril 18, 1978