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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimetry, Acetaminophen
510(k) Number K882719
Device Name EASY-TEST EMIT ACETAMINOPHEN (ACTM) NO. 16653
Applicant
Em Diagnostic Systems, Inc.
480 Democrat Rd.
Gibbstown,  NJ  08027
Applicant Contact BENTLEY, PHD
Correspondent
Em Diagnostic Systems, Inc.
480 Democrat Rd.
Gibbstown,  NJ  08027
Correspondent Contact BENTLEY, PHD
Regulation Number862.3030
Classification Product Code
LDP  
Date Received07/01/1988
Decision Date 08/08/1988
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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