510(k) K801949
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 3, 1980
- Date Received
- August 15, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Nephelometer
- Device Class
- Class I
- Regulation Number
- 866.4540
- Review Panel
- IM
- Submission Type