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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 K780563
Device Name SINGLE VIAL LACTATE
Applicant
BOEHRINGER MANNHEIM CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
BOEHRINGER MANNHEIM CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1440
Classification Product Code
CFJ  
Date Received04/07/1978
Decision Date 04/18/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
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