CHW · Class II · 21 CFR 862.1145

FDA Product Code CHW: Titrimetric With Edta And Indicator, Calcium

Leading manufacturers include Roche Diagnostics, Biosystems S.A. and Union Carbide Corp..

3
Total
3
Cleared
179d
Avg days
1978
Since

FDA 510(k) Cleared Titrimetric With Edta And Indicator, Calcium Devices (Product Code CHW)

3 devices
1–3 of 3
Cleared Sep 09, 2020
CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV
K192730
Biosystems S.A.
Chemistry · 348d
Cleared May 08, 2012
CALCIUM GEN. 2
K113521
Roche Diagnostics
Chemistry · 161d
Cleared Sep 20, 1978
LINDE OXYGEN CONCENTRATOR MODEL LOC-HCA
K781454
Union Carbide Corp.
Chemistry · 29d

About Product Code CHW - Regulatory Context