GLK · Class II · 21 CFR 864.8625

FDA Product Code GLK: Control, Hematocrit

Leading manufacturers include Bionostics, Inc., Johnson & Johnson Professionals, Inc. and Ciba Corning Diagnostics Corp..

7
Total
7
Cleared
114d
Avg days
1989
Since

FDA 510(k) Cleared Control, Hematocrit Devices (Product Code GLK)

7 devices
1–7 of 7
Cleared Jun 24, 2002
MEDICA EASYQC HEMATOCRIT CONTROL
K021924
Bionostics, Inc.
Hematology · 13d
Cleared Jul 26, 1996
CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4
K961807
Ciba Corning Diagnostics Corp.
Chemistry · 77d
Cleared Jul 14, 1989
A.QC HCT LEVEL 1 AND 2
K893562
Johnson & Johnson Professionals, Inc.
Hematology · 66d

About Product Code GLK - Regulatory Context