Home / 510(k) Clearances / K896332

510(k) K896332

SUPPLEMENT TO ANAEROBIC MIC PANEL by Microtech Medical Systems, Inc. — Product Code JWY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 1990
Date Received
November 2, 1989
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

Other clearances by Microtech Medical Systems, Inc.

  • K935485 — FAS FASTIDIOUS MIC PANEL (February 16, 1995)
  • K901598 — FASTIDIOUS MIC PANEL (November 8, 1990)
  • K884831 — ANAEROBIC MIC PANEL (March 27, 1989)
  • K863847 — MIC - CONCEPT(TM) RX-2 (December 18, 1986)
  • K861774 — QUADRA-TITER (TM) I.D. (MODIFICATION) (May 20, 1986)
  • K860208 — QUADRA-TITER I.D. (March 3, 1986)
  • K852613 — MIC-CONCEPT SYSTEM (September 20, 1985)
  • K853745 — MIC-CONCEPT VIEWBOX (September 19, 1985)
  • K850725 — QUADRA TITER MICRO PLATES (April 30, 1985)
  • K851020 — MIC-CONCEPT INOCULATOR (March 29, 1985)

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)