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510(k) K840828

KYOTEST 8V by Kyoto Diagnostics, Inc. — Product Code JMT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 1984
Date Received
February 24, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
Device Class
Class I
Regulation Number
862.1510
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)
  • 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)
  • K840996 — URINE ANALYZER SYSTEM (May 1, 1984)
  • K840829 — KYOTEST UGK (April 19, 1984)

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  • K993850 — URINALYSIS REAGENT STRIPS (10 PARAMETERS) (January 3, 2000)
  • K990873 — DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE (September 1, 1999)
  • K954685 — URITEST - NITRITE IN URINE TEST (July 22, 1996)
  • K960888 — CHEK-STIX U.T.I. SELF-TEST (July 5, 1996)
  • K953672 — FIRST CHOICE URINARY TRACT INFECTION TEST STRIPS (July 1, 1996)