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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrators, Drug Specific
510(k) Number K033601
Device Name LABONE MICRO-PLATE COTININE 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 DANIELSON
Regulation Number862.3200
Classification Product Code
DLJ  
Subsequent Product Code
MKU  
Date Received11/14/2003
Decision Date 02/10/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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