FDA Product Code CHL: Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
Leading manufacturers include Abbott Point of Care, Inc., Radiometer Medicals Aps and Nova Biomedical Corporation.
FDA 510(k) Cleared Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph Devices (Product Code CHL)
About Product Code CHL - Regulatory Context
510(k) Submission Activity
188 total 510(k) submissions under product code CHL since 1976, with 188 receiving FDA clearance (average review time: 103 days).
Submission volume has declined in recent years - 3 submissions in the last 24 months compared to 5 in the prior period.
FDA Review Time
Recent submissions under CHL have taken an average of 214 days to reach a decision - up from 101 days historically. Manufacturers should account for longer review timelines in current project planning.
CHL devices are reviewed by the Chemistry panel. Browse all Chemistry devices →