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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 K852437
Device Name VISUAL SERUM/URINE HCG COMBO KIT
Applicant
American Bioclinical, Inc.
P.O. Box 12669
Portland,  OR  97212
Applicant Contact JAN BALDWIN
Correspondent
American Bioclinical, Inc.
P.O. Box 12669
Portland,  OR  97212
Correspondent Contact JAN BALDWIN
Regulation Number862.1155
Classification Product Code
JHI  
Date Received06/10/1985
Decision Date 07/12/1985
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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