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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 K910640
Device Name SYSTEMATE LACTATE DEHYDROGENASE (EPOS APPL) #65476
Applicant
EM DIAGNOSTIC SYSTEMS, INC.
480 DEMOCRAT RD.
GIBBSTOWN,  NJ  08027
Applicant Contact ANNA G BENTLEY
Correspondent
EM DIAGNOSTIC SYSTEMS, INC.
480 DEMOCRAT RD.
GIBBSTOWN,  NJ  08027
Correspondent Contact ANNA G BENTLEY
Regulation Number862.1440
Classification Product Code
CFJ  
Date Received02/13/1991
Decision Date 04/12/1991
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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