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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coating, Liquid, Glc
510(k) Number K882766
Device Name EMDS ACETAMINOPHEN CALIBRATOR NO. 67636/95
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 Number862.2250
Classification Product Code
DLG  
Date Received07/06/1988
Decision Date 08/23/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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