JCO
7 FDA 510(k) clearances · Product code
69 daysmedian time to decision
173 days90th percentile
7clearances measured
FDA profile
- Official device name
- Bothrops Atrox Reagent
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.8100
- Medical specialty
- Hematology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| VENOM TIEM REAGENT (K955115) | Medical Diagnostic Technologies, Inc. | 1996-04-03 |
| BATROXOBIN REAGENT (K932787) | Behring Diagnostics, Inc. | 1993-11-29 |
| FDP COLLECTION TUBES (K896033) | Medical Diagnostic Technologies, Inc. | 1989-10-27 |
| DUPONT ACA FIBRIN DEGRADATION PROD CLOTTING TUBE (K852519) | E.I. Dupont DE Nemours & Co., Inc. | 1985-08-12 |
| REPTILASE -PC (K843207) | Bio/Data Corp. | 1984-10-23 |
| REPTILASE-R HA35 (K840210) | Wellcome Diagnostics | 1984-04-23 |
| ATROXIN (K780355) | Sigma Chemical Co. | 1978-04-18 |
Track JCO automatically
Every clearance here is in the API, with alerts when new ones post.