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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 K854059
Device Name MICRO-ELISA HCG EST KIT VISI-CHECK HCG TEST KIT NO
Applicant
Bioclinical Systems, Inc.
5977 Southwest Ave.
St.Louis,  MO  63139
Applicant Contact BRUCE F WATKINS
Correspondent
Bioclinical Systems, Inc.
5977 Southwest Ave.
St.Louis,  MO  63139
Correspondent Contact BRUCE F WATKINS
Regulation Number862.1155
Classification Product Code
JHI  
Date Received10/03/1985
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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