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510(k) K183140

MTS Tetracycline 0.016 - 256 ug/mL by Liofilchem S. R. L. — Product Code JWY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 2019
Date Received
November 13, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Manual Antimicrobial Susceptibility Test Systems
Device Class
Class II
Regulation Number
866.1640
Review Panel
MI
Submission Type

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  • K192345 — MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mL (October 31, 2019)
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  • K191809 — MTS Imipenem-relebactam 0.002/4-32/4 µg/mL (August 23, 2019)
  • K190914 — MTS Doxycycline 0.016 - 256 µg/mL (May 29, 2019)

Other clearances for product code JWY

  • K252114 — MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL (October 2, 2025)
  • K252062 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin (September 25, 2025)
  • K250575 — The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreon (September 5, 2025)
  • K252014 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin (August 28, 2025)
  • K251580 — MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD) (August 20, 2025)
  • K250990 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciproflox (June 30, 2025)
  • K242843 — The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) M (June 20, 2025)
  • K250856 — ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL) (June 12, 2025)
  • K242659 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomyci (May 22, 2025)
  • K250274 — ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL) (April 30, 2025)