CJO · Class II · 21 CFR 862.1050

FDA Product Code CJO: Alpha-naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes

Leading manufacturers include Siemens Healthcare Diagnostics and Bayer Corp..

4
Total
4
Cleared
67d
Avg days
1977
Since

FDA 510(k) Cleared Alpha-naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes Devices (Product Code CJO)

4 devices
1–4 of 4
Cleared Aug 28, 2012
DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CARTRIDGE DIMENSION VISTA ALKALINE PHOSPHATASE CALIBRATOR (ALPI
K122323
Siemens Healthcare Diagnostics
Chemistry · 27d
Cleared Jul 23, 2012
DIMENSION ALKALINE PHOSPHATASE FLEX REAGENT CARTRIDGE, DIMENSION ALKALINE PHOSPHATASE CALIBRATOR
K121907
Siemens Healthcare Diagnostics
Chemistry · 24d
Cleared Jan 29, 1999
BAYER ADVIA IMS SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
K982328
Bayer Corp.
Chemistry · 211d

About Product Code CJO - Regulatory Context