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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 K853372
Device Name GEMSTAR IPA THEOPHYLLINE TEST KIT
Applicant
Electro-Nucleonics Laboratories, Inc.
7101 Riverwood Dr.
Columbia,  MD  21046
Applicant Contact EUGENE H LABREC
Correspondent
Electro-Nucleonics Laboratories, Inc.
7101 Riverwood Dr.
Columbia,  MD  21046
Correspondent Contact EUGENE H LABREC
Regulation Number862.3880
Classification Product Code
KLS  
Date Received08/12/1985
Decision Date 09/04/1985
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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