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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 K894081
Device Name ROCHO ISOMUNE - LD
Applicant
ROCHE DIAGNOSTIC SYSTEMS, INC.
ONE SUNSET AVE.
MONTCLAIR,  NJ  07042
Applicant Contact ALEX WESOLOWSKI
Correspondent
ROCHE DIAGNOSTIC SYSTEMS, INC.
ONE SUNSET AVE.
MONTCLAIR,  NJ  07042
Correspondent Contact ALEX WESOLOWSKI
Regulation Number862.1445
Classification Product Code
CFE  
Date Received06/08/1989
Decision Date 08/31/1989
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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