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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 K772017
Device Name IN VITRO THEOPHYLLINE RIA TEST
Applicant
Clinical Assays, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Clinical Assays, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.3880
Classification Product Code
KLS  
Date Received10/26/1977
Decision Date 03/27/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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