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510(k) K102188

CYBOW READER, MODELS 300 & 720 by DFI Co., Ltd. — Product Code KQO

K102188 is an FDA 510(k) premarket notification submitted by DFI Co., Ltd. for the device "CYBOW READER, MODELS 300 & 720". The FDA issued a decision of Substantially Equivalent on August 9, 2011. The device falls under product code KQO (Automated Urinalysis System), a Class I device regulated under 21 CFR 862.2900. DFI Co., Ltd. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 2011
Date Received
August 3, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Automated Urinalysis System
Device Class
Class I
Regulation Number
862.2900
Review Panel
CH
Submission Type

Other clearances by DFI Co., Ltd.

  • K181024 — DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips (May 23, 2018)
  • K171521 — DUS R-50S (Urine Chemistry system) (February 16, 2018)
  • K052525 — CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS (March 29, 2006)

Other clearances for product code KQO

  • K141874 — URISCAN OPTIMA (May 28, 2015)
  • K142543 — Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid (May 11, 2015)
  • K140717 — CLINITEK NOVUS; AUTOMATED URINE CHEMISTRY ANALYZER, 10 URINALYSIS CASSETTE, CALI (November 17, 2014)
  • K121456 — AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET (February 1, 2013)
  • K101852 — CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT (March 23, 2011)
  • K091472 — URITEST 50 AND URITEST 500 URINE ANALYZER (April 27, 2010)
  • K093555 — COBAS U411 TEST SYSTEM (April 2, 2010)
  • K093098 — AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM (December 23, 2009)
  • K070929 — ACON U120 URINE ANALYZER, MODEL U111-101 (July 30, 2007)
  • K053253 — HEMOCUE ALBUMIN 201 ANALYZING SYSTEM (February 17, 2006)

FDA data resources