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510(k) K884831

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

K884831 is an FDA 510(k) premarket notification submitted by Microtech Medical Systems, Inc. for the device "ANAEROBIC MIC PANEL". The FDA issued a decision of Substantially Equivalent on March 27, 1989. The device falls under product code JWY (Manual Antimicrobial Susceptibility Test Systems), a Class II device regulated under 21 CFR 866.1640. Microtech Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 1989
Date Received
November 18, 1988
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)
  • K896332 — SUPPLEMENT TO ANAEROBIC MIC PANEL (February 5, 1990)
  • 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

  • K260447 — ETEST Gepotidacin (GEP) (0.016-256 µg/mL) (April 21, 2026)
  • K260696 — MTS Gepotidacin 0.016-256 µg/mL (April 17, 2026)
  • 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)

FDA data resources