510(k) K023655
K023655 is an FDA 510(k) premarket notification submitted by Conception Technologies for the device "ENHANCE HTF MEDIUM WITH HEPES". The FDA issued a decision of Substantially Equivalent on December 13, 2002. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180. Conception Technologies has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 13, 2002
- Date Received
- October 30, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Media, Reproductive
- Device Class
- Class II
- Regulation Number
- 884.6180
- Review Panel
- OB
- Submission Type