510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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GKGClass II

Centrifuge, Hematocrit

21 CFR 864.6400 / Hematology
FDA source (opens on fda.gov)

GKG is the FDA product code for Centrifuge, Hematocrit, a class II device type, regulated under 21 CFR 864.6400. As of , FDA records hold 11 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
GKG
Device name
Centrifuge, Hematocrit
Regulation
21 CFR 864.6400
Device class
Class II
Review panel
Hematology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
11
Ingested recalls
4

Clearances, product code GKG

By decision year
11 clearances under product code GKG with a decision year between 1982 and 1996, 1982 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code GKG by decision year
YearClearances
19823
19891
19911
19922
19932
19962

Applicants with the most clearances

Product code GKG
Applicants holding the most 510(k) clearances under product code GKG
ApplicantClearances
BD Becton Dickinson Vacutainer Systems Preanalytic2
Separation Technology, Inc.2
Boehringer Mannheim Corp.1
Fisher Scientific Company L.L.C.1
Labnet Intl., Inc.1
Micro Diagnostics Corp.1
Novonx, Inc.1
Stat-Spin Technologies1
bioMerieux, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 16 companies shown, in name order