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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)
510(k) Number K033865
Device Name IDEIA PCE CHLAMYDIA
Applicant
Dakocytomation, Ltd.
Denmark House
Angel Drove
Ely, Cambridgeshire,  GB CB7 4ET
Applicant Contact JENNIE OATES
Correspondent
Dakocytomation, Ltd.
Denmark House
Angel Drove
Ely, Cambridgeshire,  GB CB7 4ET
Correspondent Contact JENNIE OATES
Regulation Number866.3120
Classification Product Code
LJC  
Date Received12/12/2003
Decision Date 01/21/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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