510(k) K080085
K080085 is an FDA 510(k) premarket notification submitted by Thermo Fisher Scientific for the device "MAS TOX CONTROL". The FDA issued a decision of Substantially Equivalent on April 30, 2008. The device falls under product code DIF (Drug Mixture Control Materials), a Class I device regulated under 21 CFR 862.3280. Thermo Fisher Scientific has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 30, 2008
- Date Received
- January 11, 2008
- 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