FDA product code JCO: Bothrops Atrox Reagent
JCO is the FDA product code for bothrops atrox reagent. It is a Class II device, regulated under 21 CFR 864.8100 and reviewed by the Hematology panel. FDA has cleared 7 510(k) submissions under JCO, from 6 different applicants. The average 510(k) review took 85 days (median 69).
Classification
| Field | Value |
|---|---|
| Device name | Bothrops Atrox Reagent |
| Device class | Class II |
| Regulation | 21 CFR 864.8100 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every JCO clearance
Top JCO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medical Diagnostic Technologies, Inc. | 2 | 1996-04-03 |
| Behring Diagnostics, Inc. | 1 | 1993-11-29 |
| E.I. Dupont DE Nemours & Co., Inc. | 1 | 1985-08-12 |
| Bio/Data Corp. | 1 | 1984-10-23 |
| Wellcome Diagnostics | 1 | 1984-04-23 |
1 more applicants have JCO clearances. See the full list in Caduvo.
Most recent JCO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K955115 | Medical Diagnostic Technologies, Inc. | VENOM TIEM REAGENT | 1996-04-03 | 146 |
| K932787 | Behring Diagnostics, Inc. | BATROXOBIN REAGENT | 1993-11-29 | 173 |
| K896033 | Medical Diagnostic Technologies, Inc. | FDP COLLECTION TUBES | 1989-10-27 | 11 |
| K852519 | E.I. Dupont DE Nemours & Co., Inc. | DUPONT ACA FIBRIN DEGRADATION PROD CLOTTING TUBE | 1985-08-12 | 56 |
| K843207 | Bio/Data Corp. | REPTILASE -PC | 1984-10-23 | 69 |
Recalls for JCO devices
openFDA lists no recalls for product code JCO.
Frequently asked questions
What is FDA product code JCO?
JCO is the FDA product code for bothrops atrox reagent. It is a Class II device, regulated under 21 CFR 864.8100 and reviewed by the Hematology panel.
What device class is JCO?
Class II, regulation 21 CFR 864.8100. Typical premarket route: 510(k).
How long does a 510(k) take for product code JCO?
Across 7 cleared submissions the average was 85 days from receipt to decision (median 69).
Which companies have the most JCO clearances?
Medical Diagnostic Technologies, Inc. (2); Behring Diagnostics, Inc. (1); E.I. Dupont DE Nemours & Co., Inc. (1); Bio/Data Corp. (1); Wellcome Diagnostics (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JCO
- Run a recall and safety report across every JCO manufacturer
- Watch product code JCO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Hematology product codes · FDA product code lookup · 510(k) database search · 510(k) review times