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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name enzymatic esterase--oxidase, cholesterol
510(k) Number K923504
Device Name CHOLESTEROL ENZYMATIC ENDPOINT
Applicant
RANDOX LABORATORIES, LTD.
ARDMORE, DIAMOND ROAD
CRUMLIN, BT29 4QY CO.
ANTRIM, N. IRELAND,  IR
Applicant Contact John Lamont
Correspondent
RANDOX LABORATORIES, LTD.
ARDMORE, DIAMOND ROAD
CRUMLIN, BT29 4QY CO.
ANTRIM, N. IRELAND,  IR
Correspondent Contact John Lamont
Regulation Number862.1175
Classification Product Code
CHH  
Date Received07/15/1992
Decision Date 01/10/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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