Pasco Mic/Id Gram-Positive Panel
FDA 510(k) K895215 · Difco Laboratories, Inc.
510(k) numberK895215
Submission
- Device name
- Pasco Mic/Id Gram-Positive Panel
- Applicant
- Difco Laboratories, Inc.
Detroit, MI, US - Received
- August 18, 1989
- Decision date
- January 29, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| 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 |
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Questions and answers
When was Pasco Mic/Id Gram-Positive Panel cleared by the FDA?
Pasco Mic/Id Gram-Positive Panel (K895215) received a 510(k) decision of Substantially Equivalent on January 29, 1990, 164 days after the submission was received.
What is the product code of K895215?
The FDA product code is JWY – Manual Antimicrobial Susceptibility Test Systems, a Class II (moderate risk) device regulated under 21 CFR 866.1640.