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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
510(k) Number K840828
Device Name KYOTEST 8V
Applicant
Kyoto Diagnostics, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Kyoto Diagnostics, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.1510
Classification Product Code
JMT  
Date Received02/24/1984
Decision Date 05/14/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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