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510(k) K861312

LYFO-KWIK (TM) COAGULASE PLASMA by Micro-Bio-Logics — Product Code JTL

K861312 is an FDA 510(k) premarket notification submitted by Micro-Bio-Logics for the device "LYFO-KWIK (TM) COAGULASE PLASMA". The FDA issued a decision of Substantially Equivalent on April 18, 1986. The device falls under product code JTL (Plasma, Coagulase, Human, Horse And Rabbit), a Class I device regulated under 21 CFR 866.2160. Micro-Bio-Logics has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 1986
Date Received
April 8, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plasma, Coagulase, Human, Horse And Rabbit
Device Class
Class I
Regulation Number
866.2160
Review Panel
MI
Submission Type

Other clearances by Micro-Bio-Logics

  • K870731 — LYFO KWIK(TM) RUS KIT (June 17, 1987)
  • 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)
  • K844014 — ONO/CO-TWO (TM) SYSTEMS (October 31, 1984)
  • K842129 — LYFO-DISK MICROORGANISMS (July 3, 1984)

Other clearances for product code JTL

  • K950706 — DRYSLIDE COAGULASE (May 16, 1995)
  • K883333 — RABBIT PLASMA FIBRINOGEN (RPF) SUPPLEMENT (August 25, 1988)
  • K870945 — RABBIT PLASMA FIBRINOGEN SUPPLEMENT SR 122 (June 10, 1987)
  • K840553 — HEMASTAPH (April 13, 1984)
  • K833988 — API STAPHASE III (December 22, 1983)
  • K833858 — COAGULASE PLASMA, HORSE & RABBIT EDTA (December 8, 1983)
  • K822988 — COAGULASE PLASMA-CITRATED & EDTA (November 5, 1982)
  • K820177 — COAGULASE PLASMA (February 5, 1982)
  • K812602 — RABBIT COAGULASE PLASMA (September 29, 1981)
  • K811982 — STAPHASE* (July 28, 1981)

FDA data resources