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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 K923508
Device Name TRIGLYCERIDES GPO-PAP
Applicant
RANDOX LABORATORIES, LTD.
ARDMORE, DIAMOND ROAD
CRUMLIN, BT29 4QY CO.
ANTRIM, N. IRELAND,  IR
Applicant Contact JOH LAMONT
Correspondent
RANDOX LABORATORIES, LTD.
ARDMORE, DIAMOND ROAD
CRUMLIN, BT29 4QY CO.
ANTRIM, N. IRELAND,  IR
Correspondent Contact JOH LAMONT
Regulation Number862.1705
Classification Product Code
CDT  
Date Received07/15/1992
Decision Date 07/28/1993
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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