510(k) K904301
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 9, 1990
- Date Received
- September 19, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Colorimetry, Salicylate
- Device Class
- Class II
- Regulation Number
- 862.3830
- Review Panel
- TX
- Submission Type