510(k) K873401
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 23, 1987
- Date Received
- August 24, 1987
- 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