KMS · Class II · 21 CFR 862.1160

FDA Product Code KMS: Phenolphthalein Colorimetry, Carbon-dioxide

Leading manufacturers include Gamma Enterprises, Inc., Diagnostic Solutions, Inc. and American Research Products Co..

5
Total
5
Cleared
44d
Avg days
1978
Since

FDA 510(k) Cleared Phenolphthalein Colorimetry, Carbon-dioxide Devices (Product Code KMS)

5 devices
1–5 of 5
Cleared Aug 13, 1987
CARBON DIOXIDE
K872886
Catachem, Inc.
Chemistry · 22d
Cleared Mar 13, 1987
AMRESCO FLOW PAC CARBON DIOXIDE (CO2) REAGENTS
K870025
American Research Products Co.
Chemistry · 67d
Cleared May 30, 1980
REAGENTS FOR DETERM. CO2 IN HUMAN SERUM
K800681
Diagnostic Solutions, Inc.
Chemistry · 65d
Cleared May 03, 1978
CARBON DIOXIDE REAGENTS
K780506
Gamma Enterprises, Inc.
Chemistry · 34d

About Product Code KMS - Regulatory Context