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

Apparatus, Automated Blood Cell Diluting

21 CFR 864.5240 / Hematology
FDA source (opens on fda.gov)

GKH is the FDA product code for Apparatus, Automated Blood Cell Diluting, a class I device type, regulated under 21 CFR 864.5240. As of , FDA records hold 14 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
GKH
Device name
Apparatus, Automated Blood Cell Diluting
Regulation
21 CFR 864.5240
Device class
Class I
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
14
Ingested recalls
2

Clearances, product code GKH

By decision year
14 clearances under product code GKH with a decision year between 1977 and 2010, 1984 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code GKH by decision year
YearClearances
19771
19791
19821
19842
19851
19881
19901
19921
19941
20022
20041
20101

Applicants with the most clearances

Product code GKH
Applicants holding the most 510(k) clearances under product code GKH
ApplicantClearances
Abbott Diagnostics2
Immunicon Corp.2
BD Becton Dickinson Vacutainer Systems Preanalytic1
Siemens Healthcare Diagnostics Inc.1
Coulter Corp.1
Coulter Electronics, Inc.1
Innovative Medical Systems, Inc.1
Ortho Diagnostics, Inc.1
R & D Systems, Inc.1
Royco Instruments1

Companies listing this code with FDA

Companies whose registered establishments list this code