MRSASelect II
FDA 510(k) K171061 · Bio-Rad
510(k) numberK171061
Submission
- Device name
- MRSASelect II
- Applicant
- Bio-Rad
92430 Marnes-La-Coquette, FR - Received
- April 10, 2017
- Decision date
- December 28, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JSO – Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.1700
- Specialty
- Microbiology
Other 510(k)s with product code JSO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K190553 | HardyCHROM CREJSO · Traditional | Hardy Diagnostics | 04/29/2019SE |
| K181092 | CHROMID CARBA agar (CARB)JSO · Traditional | Biomerieux S.A. | 07/06/2018SE |
| K162620 | Remel Spectra ESBLJSO · Traditional | Remel, Inc. | 05/01/2017SE |
| K160512 | HardyCHROM ESBLJSO · Traditional | Hardy Diagnostics | 11/15/2016SE |
| K162076 | chromID MRSAJSO · Traditional | bioMerieux, Inc. | 10/25/2016SE |
| K151688 | chromID MRSAJSO · Traditional | bioMerieux, Inc. | 03/11/2016SE |
| K122187 | Vreselect Culture MediumJSO · Traditional | Bio-Rad | 11/06/2012SE |
| K103684 | Vreselect Culture MediumJSO · Traditional | Bio-Rad | 10/21/2011SE |
| K102922 | Hardychrom MrsaJSO · Traditional | Hardy Diagnostics | 05/04/2011SE |
| K100589 | Mrsa Select - Skin and Soft Tissue Wound SpecimensJSO · Traditional | Bio-Rad | 10/29/2010SE |
More from Bio-Rad
| 510(k) | Device | Decision |
|---|---|---|
| K122187 | Vreselect Culture MediumJSO · Traditional | 11/06/2012SE |
| K103684 | Vreselect Culture MediumJSO · Traditional | 10/21/2011SE |
| K093678 | Platelia Aspergillus Eia Model 62793NOM · Traditional | 01/13/2011SE |
| K100589 | Mrsa Select - Skin and Soft Tissue Wound SpecimensJSO · Traditional | 10/29/2010SE |
| K081362 | Platelia Lyme IgmLSR · Traditional | 06/26/2008SE |
| K081212 | Mrsaselect - Extended IncubationJSO · Traditional | 06/13/2008SE |
| K080012 | Platelia Lyme Igg AssayLSR · Traditional | 05/08/2008SE |
| K070361 | MrsaselectJSO · Traditional | 09/13/2007SE |
| K060641 | Platelia Aspergillus Eia, Model 62793NOM · Traditional | 06/02/2006SE |
| K052838 | Liquichek Diabetes Control, Level 1,2,3,4GGM · Traditional | 11/09/2005SE |
Questions and answers
When was MRSASelect II cleared by the FDA?
MRSASelect II (K171061) received a 510(k) decision of Substantially Equivalent on December 28, 2017, 262 days after the submission was received.
What is the product code of K171061?
The FDA product code is JSO – Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar, a Class II (moderate risk) device regulated under 21 CFR 866.1700.