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

Instrument, Automated Platelet Counting

21 CFR 864.5200 / Hematology
FDA source (opens on fda.gov)

GKX is the FDA product code for Instrument, Automated Platelet Counting, a class II device type, regulated under 21 CFR 864.5200. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GKX
Device name
Instrument, Automated Platelet Counting
Regulation
21 CFR 864.5200
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
2
Ingested recalls
0

Clearances, product code GKX

By decision year
2 clearances under product code GKX with a decision year between 1984 and 2002, 1984 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GKX by decision year
YearClearances
19841
20021

Applicants with the most clearances

Product code GKX
Applicants holding the most 510(k) clearances under product code GKX
ApplicantClearances
Horiba Instruments Incorporated1
Gainor Medical1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code GKX.