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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 K854989
Device Name CANWEST-PREGBLUE
Applicant
Canwest Medictex, Inc.
3588 Valley Dr.
Vancouver B.C.,  CA
Applicant Contact CHING-CHAN CHEN
Correspondent
Canwest Medictex, Inc.
3588 Valley Dr.
Vancouver B.C.,  CA
Correspondent Contact CHING-CHAN CHEN
Regulation Number862.1155
Classification Product Code
JHI  
Date Received12/12/1985
Decision Date 01/13/1986
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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