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510(k) K855198

INDI KWIK (TM) CO/TWO KIT by Micro-Bio-Logics — Product Code JTR

K855198 is an FDA 510(k) premarket notification submitted by Micro-Bio-Logics for the device "INDI KWIK (TM) CO/TWO KIT". The FDA issued a decision of Substantially Equivalent on January 14, 1986. The device falls under product code JTR (Kit, Quality Control For Culture Media), a Class I device regulated under 21 CFR 866.2480. Micro-Bio-Logics has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 1986
Date Received
December 27, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Quality Control For Culture Media
Device Class
Class I
Regulation Number
866.2480
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)
  • K852998 — NEISSERIA - KWIK PLUS (July 23, 1985)
  • K851978 — LYFO-KWIK OMI KIT (June 4, 1985)
  • K844014 — ONO/CO-TWO (TM) SYSTEMS (October 31, 1984)
  • K842129 — LYFO-DISK MICROORGANISMS (July 3, 1984)

Other clearances for product code JTR

  • K871121 — PROTECT T.M. (April 14, 1987)
  • K862914 — FEKAL CHECK PARASITOLOGY CONTROL SLIDE (September 16, 1986)
  • K861022 — KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMS (April 4, 1986)
  • K842579 — B.E.C. GROWTH CHEK MICROBIAL SUSPENSIONS (July 27, 1984)
  • K842129 — LYFO-DISK MICROORGANISMS (July 3, 1984)
  • K831653 — LYOPHILIZED MICROORGANISMS (July 28, 1983)
  • K830133 — Q-CHECK CULTI-LOOPS (February 9, 1983)
  • K822954 — MICROTECH BACTERIAL CONTROLS (November 16, 1982)
  • K821660 — BIO-CHECK GRAM STAIN CONTROL (June 25, 1982)
  • K820064 — SUSCEPTROL (January 28, 1982)

FDA data resources