FDA Product Code NDW: Assay, Porphyrin, Spectrophotometry, Lithium
Leading manufacturers include Diazyme Laboratories, Inc..
FDA 510(k) Cleared Assay, Porphyrin, Spectrophotometry, Lithium Devices (Product Code NDW)
About Product Code NDW - Regulatory Context
510(k) Submission Activity
7 total 510(k) submissions under product code NDW since 2001, with 7 receiving FDA clearance (average review time: 204 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under NDW have taken an average of 266 days to reach a decision - up from 194 days historically. Manufacturers should account for longer review timelines in current project planning.
NDW devices are reviewed by the Chemistry panel. Browse all Chemistry devices →