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

Hand-Tally, Differential

21 CFR 864.6160 / Hematology
FDA source (opens on fda.gov)

GKM is the FDA product code for Hand-Tally, Differential, a class I device type, regulated under 21 CFR 864.6160. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GKM
Device name
Hand-Tally, Differential
Regulation
21 CFR 864.6160
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
4
Ingested recalls
0

Clearances, product code GKM

By decision year
4 clearances under product code GKM with a decision year between 1977 and 1988, 1977 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GKM by decision year
YearClearances
19771
19841
19861
19881

Applicants with the most clearances

Product code GKM
Applicants holding the most 510(k) clearances under product code GKM
ApplicantClearances
Coulter Electronics, Inc.1
Future Impex Corp.1
Instrumentation Laboratory Co.1
Scientific Products1

Companies listing this code with FDA

Companies whose registered establishments list this code