Timer, Clot, Automated
The Timer, Clot, Automated (product code GKN) is an automated coagulation instrument used to detect and record the endpoint of clot formation in coagulation assays, providing objective and reproducible results for tests such as prothrombin time and activated partial thromboplastin time. This device is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. Regulated under 21 CFR 864.5400 in the Hematology specialty (HE), it is eligible for third-party review.
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Basic Information
- Product Code
- GKN
- Device Class
- FDA class 2
- Regulation Number
- 864.5400
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K953870 | ACTTRAC ELECTRONIC CONTROL DEVICE FOR THE ACT & ACT II COAGULATION INSTRUMENTS | Oct 31, 1995 | Substantially Equivalent | Medtronic Vascular |
| K940426 | MEDTRONIC HEMOTEC ACT II AUTOMATED COAGULATION TIMER | Sep 20, 1994 | Substantially Equivalent | Medtronic Hemotec, Inc. |
| K913320 | MIL CM-II COAGULATION MACHINE | Jun 16, 1992 | Substantially Equivalent | Medical Innovations Corp. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.