Microscan Microstrep Plus Panel New Antimicrobial-Cefepime
FDA 510(k) K021188 · Dade Microscan, Inc.
510(k) numberK021188
Submission
- Device name
- Microscan Microstrep Plus Panel New Antimicrobial-Cefepime
- Applicant
- Dade Microscan, Inc.
West Sacramento, CA, US - Received
- April 15, 2002
- Decision date
- June 6, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
|---|---|---|
| K043589 | Microscan Dried Gram-Positive Mic/Combo Panels - ErtapenemJWY · Traditional | 02/14/2005SE |
| K023202 | Microscan Synergies PlusJWY · Special | 10/23/2002SE |
| K021184 | Microscan Microstrep Plus Panel New Antimicrobial-ClindamycinLTT · Traditional | 06/20/2002SE |
| K021181 | Microscan Microstrep Plus Panel New Anticrobial-ClarithromycinJWY · Traditional | 06/17/2002SE |
| K021018 | Microscan Microstrep Plus Panel - ChloramphenicolJWY · Traditional | 06/11/2002SE |
| K021169 | Microstrep Plus Panel, AzithromycinJWY · Traditional | 06/06/2002SE |
| K021111 | Microscan Microstrep Plus Panel New Antimicrobial - CefotaximeLTT · Traditional | 06/06/2002SE |
| K021110 | Microscan Microstrep Plus Panel New Antimicrobial- CeftriaxoneJWY · Traditional | 06/06/2002SE |
| K021078 | Microscan Microstrep Plus Panel New Antimicrobial-ErythromycinLTT · Traditional | 06/06/2002SE |
| K020938 | Microscan Microstrep Plus Panel-MeropenemJWY · Traditional | 06/03/2002SE |
Questions and answers
When was Microscan Microstrep Plus Panel New Antimicrobial-Cefepime cleared by the FDA?
Microscan Microstrep Plus Panel New Antimicrobial-Cefepime (K021188) received a 510(k) decision of Substantially Equivalent on June 6, 2002, 52 days after the submission was received.
What is the product code of K021188?
The FDA product code is JWY – Manual Antimicrobial Susceptibility Test Systems, a Class II (moderate risk) device regulated under 21 CFR 866.1640.