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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 K854183
Device Name IN VITRO TEST DETERMINATION OF THEOPHYLLINE
Applicant
Clinical Data, Inc.
1172 Commonwealth Ave.
Boston,  MA  02134
Applicant Contact ISRAEL M STEIN
Correspondent
Clinical Data, Inc.
1172 Commonwealth Ave.
Boston,  MA  02134
Correspondent Contact ISRAEL M STEIN
Regulation Number862.3880
Classification Product Code
KLS  
Date Received10/15/1985
Decision Date 12/19/1985
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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