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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrophoretic, Lactate Dehydrogenase Isoenzymes
510(k) Number K802628
Device Name PARAGON ELECTROPHORESIS LACTATE REAG.KIT
Applicant
BECKMAN INSTRUMENTS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
BECKMAN INSTRUMENTS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1445
Classification Product Code
CFE  
Date Received10/23/1980
Decision Date 12/11/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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