510(k) K103656
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 24, 2011
- Date Received
- December 15, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Drug Mixture Control Materials
- Device Class
- Class I
- Regulation Number
- 862.3280
- Review Panel
- TX
- Submission Type