FDA Product Code
FDA Product Code JCO — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.8100
510(k) Clearances — 7 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K955115 | VENOM TIEM REAGENT | Medical Diagnostic Technologies, Inc. | 1996-04-03 | Traditional | PDF ↗ |
| K932787 | BATROXOBIN REAGENT | Behring Diagnostics, Inc. | 1993-11-29 | Traditional | PDF ↗ |
| K896033 | FDP COLLECTION TUBES | Medical Diagnostic Technologies, Inc. | 1989-10-27 | Traditional | PDF ↗ |
| K852519 | DUPONT ACA FIBRIN DEGRADATION PROD CLOTTING TUBE | E.I. Dupont DE Nemours & Co., Inc. | 1985-08-12 | Traditional | PDF ↗ |
| K843207 | REPTILASE -PC | Bio/Data Corp. | 1984-10-23 | Traditional | PDF ↗ |
| K840210 | REPTILASE-R HA35 | Wellcome Diagnostics | 1984-04-23 | Traditional | PDF ↗ |
| K780355 | ATROXIN | Sigma Chemical Co. | 1978-04-18 | Traditional | PDF ↗ |
Product code JCO · Class II · Hematology. Data: openFDA.