Remel Spectra ESBL
FDA 510(k) K162620 · Remel, Inc.
510(k) numberK162620
Submission
- Device name
- Remel Spectra ESBL
- Applicant
- Remel, Inc.
Lenexa, KS, US - Received
- September 20, 2016
- Decision date
- May 1, 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 |
| K171061 | MRSASelect IIJSO · Traditional | Bio-Rad | 12/28/2017SE |
| 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 |
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|---|---|---|
| K131804 | Remel Xpect Flu A&BGNX · Special | 07/12/2013SE |
| K092407 | Remel Spectra MrsaJSO · Traditional | 10/08/2010SE |
| K072827 | Rpmi 1640 Agar W/Mops and 2% GlucoseMJE · Traditional | 11/26/2007SE |
| K041951 | Xpect Clostridium Difficile Toxin A/BLLH · Traditional | 11/15/2004SE |
| K033479 | Prospect Clostridium Difficile Toxin A/B Microplate AssayLLH · Traditional | 02/26/2004SE |
| K031942 | Xpect Giardia Lateral Flow Assay, Model 2450020MHI · Traditional | 11/18/2003SE |
| K031965 | Xpect Cryptosporidium Lateral Flow Assay, Model 2451020MHJ · Traditional | 11/14/2003SE |
| K031834 | Xpect Giardia/Cryptosporidium Lateral Flow AssayMHI · Traditional | 11/10/2003SE |
| K031565 | Xpect Influenza A/BPSZ · Traditional | 07/17/2003SE |
| K013711 | Bacti-Swab DryLIO · Traditional | 11/26/2001SE |
Questions and answers
When was Remel Spectra ESBL cleared by the FDA?
Remel Spectra ESBL (K162620) received a 510(k) decision of Substantially Equivalent on May 1, 2017, 223 days after the submission was received.
What is the product code of K162620?
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.