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510(k) K844014

ONO/CO-TWO (TM) SYSTEMS by Micro-Bio-Logics — Product Code JTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1984
Date Received
October 12, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, For Isolation Of Pathogenic Neisseria
Device Class
Class II
Regulation Number
866.2410
Review Panel
MI
Submission Type

Other clearances by Micro-Bio-Logics

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  • K855172 — KWI (TM) G-CO/TWO (February 20, 1986)
  • K855198 — INDI KWIK (TM) CO/TWO KIT (January 14, 1986)
  • K852998 — NEISSERIA - KWIK PLUS (July 23, 1985)
  • K851978 — LYFO-KWIK OMI KIT (June 4, 1985)
  • K842129 — LYFO-DISK MICROORGANISMS (July 3, 1984)

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