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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, Barbiturate
510(k) Number K062165
Device Name VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS
Applicant
Ortho-Clinical Diagnostics
100 Indigo Creek Dr.
Rochester,  NY  14626 -5101
Applicant Contact MARLENE HANNA
Correspondent
Ortho-Clinical Diagnostics
100 Indigo Creek Dr.
Rochester,  NY  14626 -5101
Correspondent Contact MARLENE HANNA
Regulation Number862.3150
Classification Product Code
DIS  
Subsequent Product Codes
DIF   DKB  
Date Received07/28/2006
Decision Date 01/05/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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