Antimicrobial Susceptibility Test Panel
FDA 510(k) K922780 · Alamar Biosciences Laboratory, Inc.
510(k) numberK922780
Submission
- Device name
- Antimicrobial Susceptibility Test Panel
- Applicant
- Alamar Biosciences Laboratory, Inc.
Sacramento, CA, US - Received
- June 9, 1992
- Decision date
- August 20, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K941425 | Alamar Antibiotic SusceptibilityLRG · Traditional | 12/15/1994SE |
| K926248 | ReaderLRH · Traditional | 05/17/1994SE |
| K926002 | Alamar Bacterial Identification Test PanelJSS · Traditional | 09/23/1993SE |
| K925951 | ReadarLRG · Traditional | 08/31/1993SE |
| K930469 | Antimicrobial Susceptibility Test PanelJWY · Traditional | 06/25/1993SE |
| K930055 | Antimicrobial Susceptibility Test PanelJWY · Traditional | 04/05/1993SE |
| K924500 | Antimicrobial Susceptibility TestJWY · Traditional | 11/30/1992SE |
| K922003 | Antimicrobial Suscetibility Test PanelJWY · Traditional | 08/19/1992SE |
| K922168 | Antimicrobial Susceptibility Test PanelJWY · Traditional | 07/28/1992SE |
| K911558 | Antimicrobial Suscept. Test Panel NitrofurantoinJWY · Traditional | 05/15/1991SE |
Questions and answers
When was Antimicrobial Susceptibility Test Panel cleared by the FDA?
Antimicrobial Susceptibility Test Panel (K922780) received a 510(k) decision of Substantially Equivalent on August 20, 1992, 72 days after the submission was received.
What is the product code of K922780?
The FDA product code is JWY – Manual Antimicrobial Susceptibility Test Systems, a Class II (moderate risk) device regulated under 21 CFR 866.1640.