JCO · Class II · 21 CFR 864.8100

FDA Product Code JCO: Bothrops Atrox Reagent

Leading manufacturers include Medical Diagnostic Technologies, Inc., Sigma Chemical Co. and Wellcome Diagnostics.

7
Total
7
Cleared
85d
Avg days
1978
Since

FDA 510(k) Cleared Bothrops Atrox Reagent Devices (Product Code JCO)

7 devices
1–7 of 7
Cleared Apr 03, 1996
VENOM TIEM REAGENT
K955115
Medical Diagnostic Technologies, Inc.
Hematology · 146d
Cleared Nov 29, 1993
BATROXOBIN REAGENT
K932787
Behring Diagnostics, Inc.
Hematology · 173d
Cleared Oct 27, 1989
FDP COLLECTION TUBES
K896033
Medical Diagnostic Technologies, Inc.
Hematology · 11d
Cleared Aug 12, 1985
DUPONT ACA FIBRIN DEGRADATION PROD CLOTTING TUBE
K852519
E.I. Dupont DE Nemours & Co., Inc.
Hematology · 56d
Cleared Oct 23, 1984
REPTILASE -PC
K843207
Bio/Data Corp.
Hematology · 69d
Cleared Apr 23, 1984
REPTILASE-R HA35
K840210
Wellcome Diagnostics
Hematology · 95d
Cleared Apr 18, 1978
ATROXIN
K780355
Sigma Chemical Co.
Hematology · 46d

About Product Code JCO - Regulatory Context