JCO — Bothrops Atrox Reagent Class II
FDA product code JCO covers "Bothrops Atrox Reagent", a Class II medical device regulated under 21 CFR 864.8100. Submissions are reviewed by the Hematology panel. At least 7 recent 510(k) clearances have been granted under this product code.
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-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K955115 | medical diagnostic technologies | VENOM TIEM REAGENT | April 3, 1996 |
| K932787 | behring diagnostics | BATROXOBIN REAGENT | November 29, 1993 |
| K896033 | medical diagnostic technologies | FDP COLLECTION TUBES | October 27, 1989 |
| K852519 | e.i. dupont de nemours and co | DUPONT ACA FIBRIN DEGRADATION PROD CLOTTING TUBE | August 12, 1985 |
| K843207 | bio/data | REPTILASE -PC | October 23, 1984 |
| K840210 | wellcome diagnostics | REPTILASE-R HA35 | April 23, 1984 |
| K780355 | sigma chemical | ATROXIN | April 18, 1978 |