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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 K841471
Device Name ULTRA CHEM ENZYMATIC TRIGLYCERIDE
Applicant
EM DIAGNOSTIC SYSTEMS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
EM DIAGNOSTIC SYSTEMS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number862.1705
Classification Product Code
CDT  
Date Received04/09/1984
Decision Date 05/16/1984
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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