510(k) K081212
K081212 is an FDA 510(k) premarket notification submitted by Bio-Rad for the device "MRSASELECT - EXTENDED INCUBATION". The FDA issued a decision of Substantially Equivalent on Jun 13, 2008. 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. Bio-Rad has 318 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 13, 2008
- Date Received
- Apr 29, 2008
- 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
- 510(k)