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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 K881474
Device Name VISION(R) LDH (LACTATE DEHYDROGENASE)
Applicant
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064
Applicant Contact MARY ZORC
Correspondent
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064
Correspondent Contact MARY ZORC
Regulation Number862.1440
Classification Product Code
CFJ  
Date Received04/07/1988
Decision Date 06/01/1988
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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