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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name enzyme immunoassay, quinidine
510(k) Number K941440
Device Name COBAS-FP QUINIDINE REAGENTS AND CALIBRATORS
Applicant
ROCHE DIAGNOSTIC SYSTEMS, INC.
1080 u.s. highway 202
branchburg,  NJ  08876 -3771
Applicant Contact carol l krieger
Correspondent
ROCHE DIAGNOSTIC SYSTEMS, INC.
1080 u.s. highway 202
branchburg,  NJ  08876 -3771
Correspondent Contact carol l krieger
Regulation Number862.3320
Classification Product Code
LBZ  
Subsequent Product Code
DLJ  
Date Received03/24/1994
Decision Date 07/06/1994
Decision substantially equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
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