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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Test, Pregnancy, Hcg, Over The Counter
510(k) Number K974059
Device Name ONE STEP MIDSTREAM HCG PREGNANCY TEST
Applicant
INTERNATIONAL NEWTECH DEVELOPMENT, INC.
1629 FOSTERS WAY
DELTA, BRITISH COLUMBIA,  CA V3M 6S7
Applicant Contact BENNY WANG
Correspondent
INTERNATIONAL NEWTECH DEVELOPMENT, INC.
1629 FOSTERS WAY
DELTA, BRITISH COLUMBIA,  CA V3M 6S7
Correspondent Contact BENNY WANG
Regulation Number862.1155
Classification Product Code
LCX  
Date Received10/27/1997
Decision Date 04/09/1998
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
Recalls CDRH Recalls
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