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

Cyanomethemoglobin

21 CFR 864.7500 / Hematology
FDA source (opens on fda.gov)

GKK is the FDA product code for Cyanomethemoglobin, a class II device type, regulated under 21 CFR 864.7500. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GKK
Device name
Cyanomethemoglobin
Regulation
21 CFR 864.7500
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
7
Ingested recalls
0

Clearances, product code GKK

By decision year
7 clearances under product code GKK with a decision year between 1977 and 1990, 1977 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code GKK by decision year
YearClearances
19773
19821
19881
19891
19901

Applicants with the most clearances

Product code GKK
Applicants holding the most 510(k) clearances under product code GKK
ApplicantClearances
Harleco1
Hycel, Inc.1
J.T. Baker Chemical Co.1
Kvm Technologies, Inc.1
Macomb Biotechnology, Inc.1
Omega Medical Electronics1
Reagents Applications, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code