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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 K993850
Device Name URINALYSIS REAGENT STRIPS (10 PARAMETERS)
Applicant
International Newtech Development, Inc.
1629 Fosters Way
Delta, B.C.,  CA V3M 6S7
Applicant Contact DENNIS S.L. HONG
Correspondent
International Newtech Development, Inc.
1629 Fosters Way
Delta, B.C.,  CA V3M 6S7
Correspondent Contact DENNIS S.L. HONG
Regulation Number862.1510
Classification Product Code
JMT  
Subsequent Product Codes
CDM   CEN   CIN   JIL   JIN  
JIO   JIR   JJB   JMA   JMZ   JRE  
LJX  
Date Received11/12/1999
Decision Date 01/03/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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