GIG · Class II · 21 CFR 864.7500

FDA Product Code GIG: Hemoglobinometer

Leading manufacturers include The Dow Chemical Co. and Randox Laboratories, Ltd..

3
Total
3
Cleared
106d
Avg days
1977
Since

FDA 510(k) Cleared Hemoglobinometer Devices (Product Code GIG)

3 devices
1–3 of 3
Cleared Dec 08, 1997
RANDOX BILIRUBIN
K973995
Randox Laboratories, Ltd.
Chemistry · 48d
Cleared Jul 21, 1977
HEMOGLOBIN ANALYZER & PERFORM. CHECK SET
K771101
The Dow Chemical Co.
Chemistry · 31d

About Product Code GIG - Regulatory Context