Cation Adjusted Mueller Hinton Broth
FDA 510(k) K925644 · Pasco Laboratories, Inc.
510(k) numberK925644
Submission
- Device name
- Cation Adjusted Mueller Hinton Broth
- Applicant
- Pasco Laboratories, Inc.
Wheat Ridge, CO, US - Received
- November 9, 1992
- Decision date
- January 15, 1993
- 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
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| K252114 | MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mLJWY · Traditional | Liofilchem s.r.l. | 10/02/2025SE |
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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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| K030933 | Pasco Mic and Mic/Id PanelsJWY · Traditional | 05/01/2003SE |
| K030620 | Pasco Mic and Mic/Id PanelsLTT · Traditional | 04/14/2003SE |
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Questions and answers
When was Cation Adjusted Mueller Hinton Broth cleared by the FDA?
Cation Adjusted Mueller Hinton Broth (K925644) received a 510(k) decision of Substantially Equivalent on January 15, 1993, 67 days after the submission was received.
What is the product code of K925644?
The FDA product code is JWY – Manual Antimicrobial Susceptibility Test Systems, a Class II (moderate risk) device regulated under 21 CFR 866.1640.