GHS · Class II · 21 CFR 864.7425

FDA Product Code GHS: Assay, Carboxyhemoglobin

Leading manufacturers include Radiometer America, Inc., Natus Medical, Inc. and Iadec, 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 Mar 11, 1998
CO-STAT(TM) END TIDAL BREATH ANALYZER
K974805
Natus Medical, Inc.
Hematology · 78d
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
Cleared Aug 03, 1977
RADIOMHTER OSM-2 HEMOXIMETER
K771263
The London Co.
Hematology · 23d
Cleared Mar 07, 1977
ECOLYZER CARBOXIMETER
K770209
Iadec, Inc.
Hematology · 35d

About Product Code GHS - Regulatory Context