MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin (0.25-64 ug/mL)
FDA 510(k) K152346 · Beckman Coulter, Inc.
510(k) numberK152346
Submission
- Device name
- MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin (0.25-64 ug/mL)
- Applicant
- Beckman Coulter, Inc.
West Sacramento, CA, US - Received
- August 20, 2015
- Decision date
- September 16, 2015
- 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
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| 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 |
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Questions and answers
When was MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin (0.25-64 ug/mL) cleared by the FDA?
MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin (0.25-64 ug/mL) (K152346) received a 510(k) decision of Substantially Equivalent on September 16, 2015, 27 days after the submission was received.
What is the product code of K152346?
The FDA product code is JWY – Manual Antimicrobial Susceptibility Test Systems, a Class II (moderate risk) device regulated under 21 CFR 866.1640.