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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimetric Method, Triglycerides
510(k) Number K971005
Device Name TRIGLYCERIDES
Applicant
Derma Media Lab., Inc.
8531 Wellsford Pl., Suite E
Santa Fe Springs,  CA  90670
Applicant Contact CHARLES C ALLAIN
Correspondent
Derma Media Lab., Inc.
8531 Wellsford Pl., Suite E
Santa Fe Springs,  CA  90670
Correspondent Contact CHARLES C ALLAIN
Regulation Number862.1705
Classification Product Code
JGY  
Date Received03/19/1997
Decision Date 04/21/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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