510(k) K121633
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 18, 2012
- Date Received
- June 4, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
- Device Class
- Class I
- Regulation Number
- 866.3480
- Review Panel
- MI
- Submission Type