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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Theophylline
510(k) Number K855227
Device Name MICRO-EIA THEOPHYLLINE TEST KIT MONOCLONAL
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 Number862.3880
Classification Product Code
KLS  
Date Received12/30/1985
Decision Date 04/11/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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