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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 K861195
Device Name DELFIA DIGOXIN
Applicant
Lkb Instruments, Inc.
9319 Gaither Rd.
Gaithersburg,  MD  20877
Applicant Contact LKB INSTRUMENTS
Correspondent
Lkb Instruments, Inc.
9319 Gaither Rd.
Gaithersburg,  MD  20877
Correspondent Contact LKB INSTRUMENTS
Regulation Number862.3320
Classification Product Code
KXT  
Date Received03/31/1986
Decision Date 07/11/1986
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
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