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510(k) K841714

KYOTEST 2V, URINE TEST REAGENT STRIP by Kyoto Diagnostics, Inc. — Product Code JIL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 1984
Date Received
April 24, 1984
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.

  • 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)
  • K841715 — KYOTEST UK 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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