JSO — Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar Class II
FDA product code JSO covers "Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar", a Class II medical device regulated under 21 CFR 866.1700. Submissions are reviewed by the Microbiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JSO
- Device Class
- Class II
- Regulation Number
- 866.1700
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K190553 | hardy diagnostics | HardyCHROM CRE | April 29, 2019 |
| K181092 | biomerieux | CHROMID CARBA agar (CARB) | July 6, 2018 |
| K171061 | bio-rad | MRSASelect II | December 28, 2017 |
| K162620 | remel | Remel Spectra ESBL | May 1, 2017 |
| K160512 | hardy diagnostics | HardyCHROM ESBL | November 15, 2016 |
| K162076 | biomerieux | chromID MRSA | October 25, 2016 |
| K151688 | biomerieux | chromID MRSA | March 11, 2016 |
| K122187 | bio-rad | VRESELECT CULTURE MEDIUM | November 6, 2012 |
| K103684 | bio-rad | VRESELECT CULTURE MEDIUM | October 21, 2011 |
| K102922 | hardy diagnostics | HARDYCHROM MRSA | May 4, 2011 |
| K100589 | bio-rad | MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS | October 29, 2010 |
| K092407 | remel | REMEL SPECTRA MRSA | October 8, 2010 |
| K092767 | becton, dickinson and | BBL CHROMAGAR MRSA II | August 20, 2010 |
| K092819 | thermo fisher scientific | REMEL SPECTRA VRE | July 15, 2010 |
| K091025 | biomerieux | CHROMID VRE AGAR, MODEL: REF 43 851 | March 2, 2010 |
| K091024 | biomerieux | CHROMID MRSA AGAR, MODEL: REF 43 841 | July 17, 2009 |
| K081212 | bio-rad | MRSASELECT - EXTENDED INCUBATION | June 13, 2008 |
| K073027 | thermo fisher scientific | SPECTRA MRSA | February 28, 2008 |
| K070361 | bio-rad | MRSASELECT | September 13, 2007 |
| K042812 | becton, dickinson and | BBLCHROMAGAR MRSA | November 22, 2004 |