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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 K971113
Device Name DMA TRIGLYCERIDES PROCEDURES
Applicant
Data Medical Associates, Inc.
845 Ave. G E.
Arlington,  TX  76011
Applicant Contact C.H. MORRIS
Correspondent
Data Medical Associates, Inc.
845 Ave. G E.
Arlington,  TX  76011
Correspondent Contact C.H. MORRIS
Regulation Number862.1705
Classification Product Code
CDT  
Date Received03/27/1997
Decision Date 05/29/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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