510(k) DEN000008
DEN000008 is an FDA 510(k) premarket notification submitted by Life Technologies, Inc. for the device "DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM)". The FDA issued a decision of De Novo Granted on February 16, 2001. The device falls under product code NDS (Media, Culture, Ex Vivo, Tissue And Cell), a Class II device regulated under 21 CFR 876.5885. Life Technologies, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- February 16, 2001
- Date Received
- December 19, 2000
- Clearance Type
- Post-NSE
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Media, Culture, Ex Vivo, Tissue And Cell
- Device Class
- Class II
- Regulation Number
- 876.5885
- Review Panel
- GU
- Submission Type