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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 K883206
Device Name LACTATE DEHYDROGENASE LDH
Applicant
Electro-Nucleonics, Inc.
8310 Guilford Rd.
Columbia,  MD  21046
Applicant Contact KAREN DARCY
Correspondent
Electro-Nucleonics, Inc.
8310 Guilford Rd.
Columbia,  MD  21046
Correspondent Contact KAREN DARCY
Regulation Number862.1440
Classification Product Code
CFJ  
Date Received07/28/1988
Decision Date 09/09/1988
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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