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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single (Specified) Analyte Controls (Assayed And Unassayed)
510(k) Number K970176
Device Name HCG CONTROLS
Applicant
International Newtech Development, Inc.
150-13500 Maycrest Way
Richmond, B.C.,  CA V6V 2N8
Applicant Contact WINNHE WONG
Correspondent
International Newtech Development, Inc.
150-13500 Maycrest Way
Richmond, B.C.,  CA V6V 2N8
Correspondent Contact WINNHE WONG
Regulation Number862.1660
Classification Product Code
JJX  
Date Received01/17/1997
Decision Date 02/06/1997
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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