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
GKFClass II

Instrument, Hematocrit, Automated

21 CFR 864.5600 / Hematology
FDA source (opens on fda.gov)

GKF is the FDA product code for Instrument, Hematocrit, Automated, a class II device type, regulated under 21 CFR 864.5600. As of , FDA records hold 15 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
GKF
Device name
Instrument, Hematocrit, Automated
Regulation
21 CFR 864.5600
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
No
Ingested clearances
15
Ingested recalls
1

Clearances, product code GKF

By decision year
15 clearances under product code GKF with a decision year between 1978 and 2016, 1998 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code GKF by decision year
YearClearances
19781
19811
19861
19872
19881
19901
19922
19951
19983
19991
20161

Applicants with the most clearances

Product code GKF
Applicants holding the most 510(k) clearances under product code GKF
ApplicantClearances
Nova Biomedical Corporation3
Fisher Scientific Company L.L.C.2
Arden Medical Systems, Inc.1
Cobe Laboratories, Inc.1
Cutter Laboratories, Inc.1
E.I. Dupont de Nemours & Co., Inc.1
In-Line Diagnostics Corp.1
Instrumentation Laboratory Co.1
Plaza Medical, Inc.1
Smash Ent., Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 17 companies shown, in name order