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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 K850079
Device Name NOW HOME PREGN. TEST KIT ENZYME IMMUNOASSAY HCG
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
LCX  
Date Received01/10/1985
Decision Date 03/05/1985
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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