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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Tobramycin
510(k) Number K854184
Device Name IN-VITRO TEST DETERMINATION OF TOBRAMYCIN
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 Number862.3900
Classification Product Code
KLB  
Date Received10/15/1985
Decision Date 12/04/1985
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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