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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, Benzodiazepine
510(k) Number K050179
Device Name RANDOX BENZODIAZEPINE CLASS ASSAY
Applicant
Randox Laboratories, Ltd.
55 Diamond Rd.
Crumlin,  GB BT29 4QY
Applicant Contact PAULINE ARMSTRONG
Correspondent
Randox Laboratories, Ltd.
55 Diamond Rd.
Crumlin,  GB BT29 4QY
Correspondent Contact PAULINE ARMSTRONG
Regulation Number862.3170
Classification Product Code
JXM  
Subsequent Product Code
DKB  
Date Received01/26/2005
Decision Date 05/17/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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