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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 K792658
Device Name COBAS-BLO REAGENTS (LACTATE DEHYDRO
Applicant
Hoffmann-La Roche, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Hoffmann-La Roche, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.1440
Classification Product Code
CFJ  
Date Received12/26/1979
Decision Date 01/17/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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