FDA Product Code
FDA Product Code JCA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.6100
510(k) Clearances — 7 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K911745 | SIMPLATE PEDIATRIC | Organon Teknika Corp. | 1991-08-09 | Traditional | PDF ↗ |
| K911996 | SURGICUTT-BLEEDING TIME DEVICE, MODIFICATION | International Technidyne Corp. | 1991-07-17 | Traditional | PDF ↗ |
| K871318 | Q.I.C. BLEEDING TIME DEVICE | Helena Laboratories | 1987-06-10 | Traditional | PDF ↗ |
| K850542 | SURGICUTT - BLEEDING TIME DEVICE | International Technidyne Corp. | 1985-03-01 | Traditional | PDF ↗ |
| K830645 | BLEEDING TIME DEVICE DISPOSABLE | American Dade | 1983-03-17 | Traditional | PDF ↗ |
| K801815 | AUTOLET | Ulster Scientific, Inc. | 1980-10-10 | Traditional | PDF ↗ |
| K761250 | SIMPLATE | General Diagnostics | 1977-03-01 | Traditional | PDF ↗ |
Product code JCA · Class II · Hematology. Data: openFDA.