GKN · Timer, Clot, Automated
Hematology · 21 CFR 864.5400 · Class 2
Overview
| Product Code | GKN |
|---|---|
| Device Name | Timer, Clot, Automated |
| Regulation | 21 CFR 864.5400 |
| Device Class | Class 2 |
| Review Panel | Hematology |
| 3rd-Party Reviewable | Yes |
Identification
A coagulation instrument is an automated or semiautomated device used to determine the onset of clot formation for in vitro coagulation studies.
Classification Rationale
Class II (special controls). A fibrometer or coagulation timer intended for use with a coagulation instrument is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Special Controls
*Classification.* Class II (special controls). A fibrometer or coagulation timer intended for use with a coagulation instrument is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K953870 | ACTTRAC ELECTRONIC CONTROL DEVICE FOR THE ACT & ACT II COAGULATION INSTRUMENTS | Medtronic Vascular | Oct 31, 1995 | SESE |
| K940426 | MEDTRONIC HEMOTEC ACT II AUTOMATED COAGULATION TIMER | Medtronic Hemotec, Inc. | Sep 20, 1994 | SESE |
| K913320 | MIL CM-II COAGULATION MACHINE | Medical Innovations Corp. | Jun 16, 1992 | SESE |
Top Applicants
- Medical Innovations Corp. — 1 clearance
- Medtronic Hemotec, Inc. — 1 clearance
- Medtronic Vascular — 1 clearance
