510(k) K092819
K092819 is an FDA 510(k) premarket notification submitted by Thermo Fisher Scientific for the device "REMEL SPECTRA VRE". The FDA issued a decision of Substantially Equivalent on July 15, 2010. The device falls under product code JSO (Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar), a Class II device regulated under 21 CFR 866.1700. Thermo Fisher Scientific has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 15, 2010
- Date Received
- September 14, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
- Device Class
- Class II
- Regulation Number
- 866.1700
- Review Panel
- MI
- Submission Type