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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, Cocaine And Cocaine Metabolites
510(k) Number K040198
Device Name LABONE COCAINE METABOLITE MICRO-PLATE EIA
Applicant
Labone, Inc.
10101 Renner Blvd.
Lenexa,  KS  66219
Applicant Contact LIUMING YU
Correspondent
Tuv America, Inc.
1775 Old Hwy. 8
New Brighton,  MN  55112
Correspondent Contact LAURA L DANIELSON
Regulation Number862.3250
Classification Product Code
DIO  
Date Received01/29/2004
Decision Date 03/05/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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