JCOClass II
Bothrops Atrox Reagent
Hematology · 21 CFR 864.8100
MDR events1All time
Recalls0All time
Registered firms4Currently listed
510(k) clearances7All time
Recent MDR events
1 adverse event reports on file
Event type breakdown
Malfunction1
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
4 firms currently registered for this product code
510(k) clearances
7 clearances for this product code
- Medical Diagnostic Technologies, Inc.Apr 3, 1996
K955115 · VENOM TIEM REAGENT
- Behring Diagnostics, Inc.Nov 29, 1993
K932787 · BATROXOBIN REAGENT
- Medical Diagnostic Technologies, Inc.Oct 27, 1989
K896033 · FDP COLLECTION TUBES
- E.I. Dupont DE Nemours & Co., Inc.Aug 12, 1985
K852519 · DUPONT ACA FIBRIN DEGRADATION PROD CLOTTING TUBE
- Bio/Data Corp.Oct 23, 1984
K843207 · REPTILASE -PC
- Wellcome DiagnosticsApr 23, 1984
K840210 · REPTILASE-R HA35
- Sigma Chemical Co.Apr 18, 1978
K780355 · ATROXIN