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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Amikacin Serum Assay
510(k) Number K873426
Device Name EASY-TEST EMIT(R) AMIKACIN (AMIK) NO. 16645
Applicant
Em Diagnostic Systems, Inc.
480 Democrat Rd.
Gibbstown,  NJ  08027
Applicant Contact RAYMOND L MILLER
Correspondent
Em Diagnostic Systems, Inc.
480 Democrat Rd.
Gibbstown,  NJ  08027
Correspondent Contact RAYMOND L MILLER
Regulation Number862.3035
Classification Product Code
KLP  
Date Received08/25/1987
Decision Date 10/29/1987
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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