GIQ · Class II · 21 CFR 864.7415

FDA Product Code GIQ: Hemoglobin S

Leading manufacturers include Isolab, Inc. and Medicus Technologies, Inc..

3
Total
3
Cleared
198d
Avg days
1988
Since

FDA 510(k) Cleared Hemoglobin S Devices (Product Code GIQ)

3 devices
1–3 of 3
Cleared Aug 14, 1996
SICKLE-2000
K955719
Medicus Technologies, Inc.
Hematology · 240d
Cleared Jan 20, 1995
QUIK-SEP QUANTITATIVE HEMOGLOBIN S ASSAY
K942276
Isolab, Inc.
Hematology · 255d

About Product Code GIQ - Regulatory Context