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510(k) K844014

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

K844014 is an FDA 510(k) premarket notification submitted by Micro-Bio-Logics for the device "ONO/CO-TWO (TM) SYSTEMS". The FDA issued a decision of Substantially Equivalent on October 31, 1984. The device falls under product code JTY (Culture Media, For Isolation Of Pathogenic Neisseria), a Class II device regulated under 21 CFR 866.2410. Micro-Bio-Logics has at least 8 other 510(k) clearances on record.

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

  • K870731 — LYFO KWIK(TM) RUS KIT (June 17, 1987)
  • K861312 — LYFO-KWIK (TM) COAGULASE PLASMA (April 18, 1986)
  • K861022 — KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMS (April 4, 1986)
  • 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)

Other clearances for product code JTY

  • K210511 — InTray GC (October 20, 2021)
  • K993033 — INTRAY GC (December 16, 1999)
  • K954986 — GC BASE W/ 1% GCHI (February 16, 1996)
  • K950196 — CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA (June 30, 1995)
  • K933122 — MICROBIOLOGICAL CULTURE MEDIA,MARTIN LEWIS AGAR (February 9, 1994)
  • K933121 — MICROBIOLOGICAL CULTURE MEDIA,CHOCOLATE AGAR (February 3, 1994)
  • K934331 — THAYER MARTIN, MODIFIED PILL POCKET (December 21, 1993)
  • K934330 — TRANSGROW (December 17, 1993)
  • K931864 — MARTIN LEWIS WITH LINOCMYCIN (December 15, 1993)
  • K881552 — PROTEOSE NO. 3 AGAR (April 18, 1988)

FDA data resources