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510(k) K935485

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 1995
Date Received
November 15, 1993
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.

  • K901598 — FASTIDIOUS MIC PANEL (November 8, 1990)
  • K896332 — SUPPLEMENT TO ANAEROBIC MIC PANEL (February 5, 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)

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