510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
GKNClass II

Timer, Clot, Automated

21 CFR 864.5400 / Hematology
FDA source (opens on fda.gov)

GKN is the FDA product code for Timer, Clot, Automated, a class II device type, regulated under 21 CFR 864.5400. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GKN
Device name
Timer, Clot, Automated
Regulation
21 CFR 864.5400
Device class
Class II
Review panel
Hematology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
3
Ingested recalls
0

Clearances, product code GKN

By decision year
3 clearances under product code GKN with a decision year between 1992 and 1995, 1992 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GKN by decision year
YearClearances
19921
19941
19951

Applicants with the most clearances

Product code GKN
Applicants holding the most 510(k) clearances under product code GKN
ApplicantClearances
Medical Innovations, Inc.1
Medtronic Hemotec, Inc.1
Medtronic, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code