Bhi W/Vancomycin Agar
FDA 510(k) K964560 · Hardy Diagnostics
510(k) numberK964560
Submission
- Device name
- Bhi W/Vancomycin Agar
- Applicant
- Hardy Diagnostics
Santa Maria, CA, US - Received
- November 13, 1996
- Decision date
- January 15, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| K171061 | MRSASelect IIJSO · Traditional | Bio-Rad | 12/28/2017SE |
| 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 |
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Questions and answers
When was Bhi W/Vancomycin Agar cleared by the FDA?
Bhi W/Vancomycin Agar (K964560) received a 510(k) decision of Substantially Equivalent on January 15, 1997, 63 days after the submission was received.
What is the product code of K964560?
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.