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510(k) K861733

ADDITIONAL KYOTEST URINE TEST REAGENT STRIPS by Kyoto Diagnostics, Inc. — Product Code JIL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 1986
Date Received
May 6, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Device Class
Class II
Regulation Number
862.1340
Review Panel
CH
Submission Type

Other clearances by Kyoto Diagnostics, Inc.

  • 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)
  • K841715 — KYOTEST UK URINE TEST REAGENT STRIP (May 31, 1984)
  • K841714 — KYOTEST 2V, URINE TEST REAGENT STRIP (May 31, 1984)
  • K841713 — KYOTEST UG URINE TEST REAGENT STRIP (May 31, 1984)
  • K840827 — KYOTEST 5V (May 14, 1984)
  • K840828 — KYOTEST 8V (May 14, 1984)
  • K840996 — URINE ANALYZER SYSTEM (May 1, 1984)
  • K840829 — KYOTEST UGK (April 19, 1984)

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  • K171521 — DUS R-50S (Urine Chemistry system) (February 16, 2018)
  • K171083 — iChemVELOCITY Automated Urine Chemistry System (May 12, 2017)
  • K160062 — AUTION ELEVEN Semi-Automated Urinalysis System (October 7, 2016)
  • K160372 — URITEK TC-201 URINE CHEMISTRY TEST SYSTEM (July 22, 2016)
  • K141289 — TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS (July 24, 2015)