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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name lipase hydrolysis/glycerol kinase enzyme, triglycerides
510(k) Number K862706
Device Name EMDS(TM) TRIGLYCERIDE TESTPACKS #67674/95
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 Number862.1705
Classification Product Code
CDT  
Date Received07/16/1986
Decision Date 08/19/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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