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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
510(k) Number K970684
Device Name LACTATE DEHYDROGENASE (LD)
Applicant
Randox Laboratories, Ltd.
Ardmore, Diamond Rd.
Crumlin,  IE BT29 4QY
Applicant Contact PONE ARMSTRONG
Correspondent
Randox Laboratories, Ltd.
Ardmore, Diamond Rd.
Crumlin,  IE BT29 4QY
Correspondent Contact PONE ARMSTRONG
Regulation Number862.1440
Classification Product Code
CFJ  
Date Received02/24/1997
Decision Date 05/07/1997
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
Recalls CDRH Recalls
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