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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Visual, Pregnancy Hcg, Prescription Use
510(k) Number K963133
Device Name PS-UNIT CASSETTE/SERUM HCG
Applicant
International Newtech Development, Inc.
150-13500 Maycrest Way
Richmond, B.C.,  CA V6V 2N8
Applicant Contact JESSE ZHU
Correspondent
International Newtech Development, Inc.
150-13500 Maycrest Way
Richmond, B.C.,  CA V6V 2N8
Correspondent Contact JESSE ZHU
Regulation Number862.1155
Classification Product Code
JHI  
Date Received08/12/1996
Decision Date 11/18/1996
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
Recalls CDRH Recalls
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