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510(k) K851978

LYFO-KWIK OMI KIT by Micro-Bio-Logics — Product Code JSS

K851978 is an FDA 510(k) premarket notification submitted by Micro-Bio-Logics for the device "LYFO-KWIK OMI KIT". The FDA issued a decision of Substantially Equivalent on June 4, 1985. The device falls under product code JSS (Kit, Identification, Enterobacteriaceae), a Class I device regulated under 21 CFR 866.2660. Micro-Bio-Logics has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 1985
Date Received
May 7, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Identification, Enterobacteriaceae
Device Class
Class I
Regulation Number
866.2660
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)
  • K844014 — ONO/CO-TWO (TM) SYSTEMS (October 31, 1984)
  • K842129 — LYFO-DISK MICROORGANISMS (July 3, 1984)

Other clearances for product code JSS

  • K150031 — hemoFISH Masterpanel (October 1, 2015)
  • K123418 — GRAM-NEGATIVE QUICKFISH BC (July 21, 2013)
  • K101558 — GNR TRAFFIC LIGHT PNA FISH (December 16, 2010)
  • K092236 — E.COLI/P. AERUGINOSA PNA FISH (December 16, 2009)
  • K092393 — EK/P. AERUGINOSA PNA FISH (September 1, 2009)
  • K082068 — E. COLI PNA FISH (June 25, 2009)
  • K081433 — EK/P. AERUGINOSA PNA FISH (March 26, 2009)
  • K081309 — E.COLI/P. AERUGINOSA PNA FISH (December 19, 2008)
  • K926002 — ALAMAR BACTERIAL IDENTIFICATION TEST PANEL (September 23, 1993)
  • K926017 — CRYSTAL RAPID STOOL/ENTERIC ID SYSTEM (March 11, 1993)

FDA data resources