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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, Digitoxin
510(k) Number K990251
Device Name DGTX FLEX REAGENT CARTRIDGE, MODEL DF36
Applicant
Dade Behring, Inc.
Bldg. 500 Mail Box 514
P.O. Box 6101
Newark,  DE  19714
Applicant Contact CATHY P CRAFT
Correspondent
Dade Behring, Inc.
Bldg. 500 Mail Box 514
P.O. Box 6101
Newark,  DE  19714
Correspondent Contact CATHY P CRAFT
Regulation Number862.3300
Classification Product Code
LFM  
Date Received01/27/1999
Decision Date 03/31/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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