GKN · Class II · 21 CFR 864.5400

FDA Product Code GKN: Timer, Clot, Automated

Leading manufacturers include Medical Innovations Corp. and Medtronic Vascular.

3
Total
3
Cleared
211d
Avg days
1992
Since

FDA 510(k) Cleared Timer, Clot, Automated Devices (Product Code GKN)

3 devices
1–3 of 3
Cleared Oct 31, 1995
ACTTRAC ELECTRONIC CONTROL DEVICE FOR THE ACT & ACT II COAGULATION INSTRUMENTS
K953870
Medtronic Vascular
Hematology · 75d
Cleared Jun 16, 1992
MIL CM-II COAGULATION MACHINE
K913320
Medical Innovations Corp.
Hematology · 327d

About Product Code GKN - Regulatory Context