MicroScan MICroSTREP plus Panels with Tetracycline (0.06-16 µg/mL)
FDA 510(k) K202423 · Beckman Coulter, Inc.
510(k) numberK202423
Submission
- Device name
- MicroScan MICroSTREP plus Panels with Tetracycline (0.06-16 µg/mL)
- Applicant
- Beckman Coulter, Inc.
West Sacramento, CA, US - Received
- August 25, 2020
- Decision date
- May 18, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JWY – Manual Antimicrobial Susceptibility Test Systems
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.1640
- Specialty
- Microbiology
Other 510(k)s with product code JWY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260447 | ETEST Gepotidacin (GEP) (0.016-256 µg/mL)JWY · Traditional | bioMérieux SA | 04/21/2026SE |
| K260696 | MTS Gepotidacin 0.016-256 µg/mLJWY · Traditional | Liofilchem s.r.l. | 04/17/2026SE |
| K252114 | MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mLJWY · Traditional | Liofilchem s.r.l. | 10/02/2025SE |
| K252062 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the…JWY · Traditional | Thermo Fisher Scientific | 09/25/2025SE |
| K250575 | The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with…JWY · Traditional | Thermo Fisher Scientific | 09/05/2025SE |
| K252014 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the…JWY · Traditional | Thermo Fisher Scientific | 08/28/2025SE |
| K251580 | MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD)JWY · Traditional | Liofilchem s.r.l. | 08/20/2025SE |
| K250990 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in…JWY · Traditional | Thermo Fisher Scientific | 06/30/2025SE |
| K242843 | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or…JWY · Traditional | Thermo Fisher Scientific | 06/20/2025SE |
| K250856 | ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL)JWY · Traditional | Biomérieux | 06/12/2025SE |
More from Biomérieux
| 510(k) | Device | Decision |
|---|---|---|
| K252169 | Access BNP IINBC · Traditional | 03/24/2026SE |
| K254059 | Access anti-HBc IgMSEI · Traditional | 03/13/2026SE |
| K253687 | Access anti-HBc TotalSEI · Traditional | 02/19/2026SE |
| K251995 | Access anti-HAV IgMLOL · Traditional | 01/27/2026SE |
| K250588 | Access Rubella IgGLFX · Traditional | 11/17/2025SE |
| K252580 | iQ200 SeriesLKM · Special | 09/10/2025SE |
| K243846 | Access anti-HAVLOL · Traditional | 09/09/2025SE |
| K243804 | MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL)…LTT · Traditional | 08/20/2025SE |
| K250036 | MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)LTT · Traditional | 08/15/2025SE |
| K243483 | Access hsTnIMMI · Traditional | 08/01/2025SE |
Questions and answers
When was MicroScan MICroSTREP plus Panels with Tetracycline (0.06-16 µg/mL) cleared by the FDA?
MicroScan MICroSTREP plus Panels with Tetracycline (0.06-16 µg/mL) (K202423) received a 510(k) decision of Substantially Equivalent on May 18, 2021, 266 days after the submission was received.
What is the product code of K202423?
The FDA product code is JWY – Manual Antimicrobial Susceptibility Test Systems, a Class II (moderate risk) device regulated under 21 CFR 866.1640.