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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cresolphthalein complexone, calcium
510(k) Number K896224
Device Name COBAS READY CALCIUM REAGENT
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 Number862.1145
Classification Product Code
CIC  
Date Received10/30/1989
Decision Date 08/17/1990
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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