GKK · Class II · 21 CFR 864.7500

FDA Product Code GKK: Cyanomethemoglobin

Leading manufacturers include Hycel, Inc., Harleco and J.T. Baker Chemical Co..

7
Total
7
Cleared
41d
Avg days
1977
Since

FDA 510(k) Cleared Cyanomethemoglobin Devices (Product Code GKK)

7 devices
1–7 of 7
Cleared Jan 25, 1990
RAICHEM TM HEMOGLOBIN REAGENT
K896922
Reagents Applications, Inc.
Hematology · 45d
Cleared Oct 24, 1989
MODIFIED HEMOGLOBIN REAGENT SET
K894951
Macomb Biotechnology, Inc.
Hematology · 96d
Cleared Oct 12, 1988
KVM PREPACK HEMATOLOGY REAGENT SET
K883992
Kvm Technologies, Inc.
Hematology · 22d
Cleared May 24, 1982
HEMOGLOBIN REAGENT SET
K821202
Omega Medical Electronics
Hematology · 27d
Cleared Sep 20, 1977
CYMET-PLUS
K771716
J.T. Baker Chemical Co.
Hematology · 8d
Cleared Jul 11, 1977
UNIPAK HEMOGLOBIN
K771090
Harleco
Chemistry · 25d
Cleared Jul 05, 1977
HEMOTOLOGY PRODU&TS (5 IN ALL)
K770803
Hycel, Inc.
Chemistry · 64d

About Product Code GKK - Regulatory Context