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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
510(k) Number K861733
Device Name ADDITIONAL KYOTEST URINE TEST REAGENT STRIPS
Applicant
Kyoto Diagnostics, Inc.
2421 S. Nappanee St.
Post Office Box 4226
Elkhart,  IN  46514
Applicant Contact JACKSON, PH.D.
Correspondent
Kyoto Diagnostics, Inc.
2421 S. Nappanee St.
Post Office Box 4226
Elkhart,  IN  46514
Correspondent Contact JACKSON, PH.D.
Regulation Number862.1340
Classification Product Code
JIL  
Date Received05/06/1986
Decision Date 07/25/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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