510(k) K872755
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 1, 1987
- Date Received
- July 13, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Analyzer, Chromosome, Automated
- Device Class
- Class II
- Regulation Number
- 864.5260
- Review Panel
- PA
- Submission Type