510(k) K761271
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 14, 1977
- Date Received
- December 20, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Porter Silber Hydrazone, 17-Hydroxycorticosteroids
- Device Class
- Class I
- Regulation Number
- 862.1385
- Review Panel
- CH
- Submission Type