GHS · Class II · 21 CFR 864.7425

FDA Product Code GHS: Assay, Carboxyhemoglobin

Leading manufacturers include Corning Medical & Scientific and Radiometer America, Inc..

5
Total
5
Cleared
61d
Avg days
1977
Since

FDA 510(k) Cleared Assay, Carboxyhemoglobin Devices (Product Code GHS)

5 devices
1–5 of 5
Cleared Jul 09, 1991
ABL520 BLOOD GAS SYSTEM
K910827
Radiometer America, Inc.
Hematology · 132d
Cleared Jun 22, 1979
TRISEDTA-BORATE ELECTROPHORESIS FILM AGA
K790943
Corning Medical & Scientific
Hematology · 35d

About Product Code GHS - Regulatory Context