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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzymatic, Carbon-Dioxide
510(k) Number K951221
Device Name TOTAL CO2
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 Number862.1160
Classification Product Code
KHS  
Date Received03/20/1995
Decision Date 02/15/1996
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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