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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 K971324
Device Name TRIGLYCERIDES, TG, OR TRIG
Applicant
CAROLINA LIQUID CHEMISTRIES CORP.
451 WEST LAMBERT RD.,
SUITE 207
BREA,  CA  92821
Applicant Contact CYNTHIA SHUGART
Correspondent
CAROLINA LIQUID CHEMISTRIES CORP.
451 WEST LAMBERT RD.,
SUITE 207
BREA,  CA  92821
Correspondent Contact CYNTHIA SHUGART
Regulation Number862.1705
Classification Product Code
CDT  
Date Received04/10/1997
Decision Date 06/20/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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