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510(k) K855172

KWI (TM) G-CO/TWO by Micro-Bio-Logics — Product Code JSK

K855172 is an FDA 510(k) premarket notification submitted by Micro-Bio-Logics for the device "KWI (TM) G-CO/TWO". The FDA issued a decision of Substantially Equivalent on February 20, 1986. The device falls under product code JSK (Supplement, Culture Media), a Class I device regulated under 21 CFR 866.2450. Micro-Bio-Logics has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 1986
Date Received
December 26, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Supplement, Culture Media
Device Class
Class I
Regulation Number
866.2450
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)
  • 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 JSK

  • K881949 — ATS NAC-PAC SET (May 25, 1988)
  • K881879 — ATS M/15 PHOSPHATE BUFFER, PRODUCT #034-42 (May 13, 1988)
  • K881566 — HEMOGLOBIN POWDER (April 18, 1988)
  • K861997 — PENICILLIN-STREPTOMYCIN-FUNGIZONE MIXTURE (June 10, 1986)
  • K861823 — GENTAMICIN SULFATE SOLUTION (50MG GENTAMICIN) (May 20, 1986)
  • K861824 — GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN) (May 20, 1986)
  • K861791 — PENICILLIN-STREPTOMYCIN-FUNGIZONE (May 20, 1986)
  • K853546 — ABBOTT CATION SUPPLEMENT SOLUTION (September 6, 1985)
  • K850302 — SUPLEX & SUPLEX DILUENT (March 22, 1985)
  • K850308 — C.L.A.T. (March 20, 1985)

FDA data resources