The following data is part of a premarket notification filed by Bio-rad with the FDA for Mrsa Select - Skin And Soft Tissue Wound Specimens.
| Device ID | K100589 |
| 510k Number | K100589 |
| Device Name: | MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS |
| Classification | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar |
| Applicant | BIO-RAD 180 Cabot Street Beverly, MA 01915 |
| Contact | Fran White |
| Correspondent | Fran White BIO-RAD 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 | 2010-03-02 |
| Decision Date | 2010-10-29 |
| Summary: | summary |