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510(k) K945997

MODIFIED FOX EXTRA GRAM POSITIVE by Micro-Media Systems, Inc. — Product Code JWY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 1995
Date Received
October 7, 1994
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 Micro-Media Systems, Inc.

  • K953422 — FOX FASTIDIOUS TEST PANELS (October 7, 1995)
  • K823738 — GRAM NEGATIVE BACTERIAL IDENTIF- PANELS (January 7, 1983)
  • K801547 — TEST PANEL FOR PRESUMP. ID/BACT. ORG (September 9, 1980)
  • K791991 — STREP-SPEC (November 13, 1979)
  • K770746 — PANEL, IDENTIFICATION, STREP, MICRO-ID (June 23, 1977)
  • K770745 — PANEL, GNF, MICRO-ID (June 23, 1977)

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