The following data is part of a premarket notification filed by Bio-rad with the FDA for Mrsaselect Ii.
| Device ID | K171061 |
| 510k Number | K171061 |
| Device Name: | MRSASelect II |
| Classification | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar |
| Applicant | Bio-Rad 3 Boulevard Raymond Poincare 92430 Marnes-la-coquette, FR 92430 |
| Contact | Sylvie Fernez |
| Correspondent | Fran White MDC Associates, LLC 180 Cabot Street Beverly, MA 01915 |
| Product Code | JSO |
| CFR Regulation Number | 866.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-10 |
| Decision Date | 2017-12-28 |
| Summary: | summary |