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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, Digoxin
510(k) Number K851032
Device Name COBAS FP REAGENTS FOR DIGOXIN & COBAS FP DIGOXIN C
Applicant
ROCHE DIAGNOSTIC SYSTEMS, INC.
11 FRANKLIN AVE.
BELLEVILLE,  NJ  07109 -3597
Applicant Contact KAFADER II
Correspondent
ROCHE DIAGNOSTIC SYSTEMS, INC.
11 FRANKLIN AVE.
BELLEVILLE,  NJ  07109 -3597
Correspondent Contact KAFADER II
Regulation Number862.3320
Classification Product Code
KXT  
Date Received03/12/1985
Decision Date 04/03/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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