FDA Product Code
FDA Product Code GKN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.5400
510(k) Clearances — 3 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K953870 | ACTTRAC ELECTRONIC CONTROL DEVICE FOR THE ACT & ACT II COAGULATION INSTRUMENTS | Medtronic Vascular | 1995-10-31 | Traditional | PDF ↗ |
| K940426 | MEDTRONIC HEMOTEC ACT II AUTOMATED COAGULATION TIMER | Medtronic Hemotec, Inc. | 1994-09-20 | Traditional | PDF ↗ |
| K913320 | MIL CM-II COAGULATION MACHINE | Medical Innovations Corp. | 1992-06-16 | Traditional | PDF ↗ |
Product code GKN · Class II · Hematology. Data: openFDA.