510(k) K852485
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 12, 1985
- Date Received
- June 11, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Media And Components, Synthetic Cell And Tissue Culture
- Device Class
- Class I
- Regulation Number
- 864.2220
- Review Panel
- PA
- Submission Type