JSO — Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar Class II
FDA Device Classification
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 |