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510(k) K840996

URINE ANALYZER SYSTEM by Kyoto Diagnostics, Inc. — Product Code KQO

K840996 is an FDA 510(k) premarket notification submitted by Kyoto Diagnostics, Inc. for the device "URINE ANALYZER SYSTEM". The FDA issued a decision of Substantially Equivalent on May 1, 1984. The device falls under product code KQO (Automated Urinalysis System), a Class I device regulated under 21 CFR 862.2900. Kyoto Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 1984
Date Received
March 8, 1984
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 Kyoto Diagnostics, Inc.

  • K861733 — ADDITIONAL KYOTEST URINE TEST REAGENT STRIPS (July 25, 1986)
  • K843003 — GLUCOSE AUTO& STAT GA-1120 (September 28, 1984)
  • K842750 — OSMOTIC PRESSURE AUTO & STAT OM-6010 (August 17, 1984)
  • K842168 — ATAGO URINE SPECIFIC GRAVITY & SERUM (July 16, 1984)
  • K841714 — KYOTEST 2V, URINE TEST REAGENT STRIP (May 31, 1984)
  • K841715 — KYOTEST UK URINE TEST REAGENT STRIP (May 31, 1984)
  • K841713 — KYOTEST UG URINE TEST REAGENT STRIP (May 31, 1984)
  • K840828 — KYOTEST 8V (May 14, 1984)
  • K840827 — KYOTEST 5V (May 14, 1984)
  • K840829 — KYOTEST UGK (April 19, 1984)

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)
  • K102188 — CYBOW READER, MODELS 300 & 720 (August 9, 2011)
  • 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)

FDA data resources