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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name bromcresol green dye-binding, albumin
510(k) Number K823574
Device Name COBAS REAGENT FOR ALBUMIN
Applicant
HOFFMANN-LA ROCHE, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
HOFFMANN-LA ROCHE, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number862.1035
Classification Product Code
CIX  
Date Received12/06/1982
Decision Date 01/07/1983
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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