Fas Fastidious Mic Panel
FDA 510(k) K935485 · Microtech Medical Systems, Inc.
510(k) numberK935485
Submission
- Device name
- Fas Fastidious Mic Panel
- Applicant
- Microtech Medical Systems, Inc.
Aurora, CO, US - Received
- November 15, 1993
- Decision date
- February 16, 1995
- 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
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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 |
More from Biomérieux
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| K901598 | Fastidious Mic PanelJWY · Traditional | 11/08/1990SE |
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| K884831 | Anaerobic Mic PanelJWY · Traditional | 03/27/1989SE |
| K863847 | Mic - Concept(Tm) RX-2JWY · Traditional | 12/18/1986SE |
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| K860208 | Quadra-Titer I.D.JSS · Traditional | 03/03/1986SE |
| K852613 | Mic-Concept SystemLTW · Traditional | 09/20/1985SE |
| K853745 | Mic-Concept ViewboxLIB · Traditional | 09/19/1985SE |
| K850725 | Quadra Titer Micro PlatesLIB · Traditional | 04/30/1985SE |
| K851020 | Mic-Concept InoculatorJTC · Traditional | 03/29/1985SE |
Questions and answers
When was Fas Fastidious Mic Panel cleared by the FDA?
Fas Fastidious Mic Panel (K935485) received a 510(k) decision of Substantially Equivalent on February 16, 1995, 458 days after the submission was received.
What is the product code of K935485?
The FDA product code is JWY – Manual Antimicrobial Susceptibility Test Systems, a Class II (moderate risk) device regulated under 21 CFR 866.1640.