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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 K872056
Device Name MODIFIED (DIRECTIONS FOR USE) FOR IDEIA(TM) TEST
Applicant
Boots-Celltech Diagnostics, Inc.
240 Bath Rd.
Slough Sl1 4et
Berkshire, England,  GB
Applicant Contact ABBOTT, PHD
Correspondent
Boots-Celltech Diagnostics, Inc.
240 Bath Rd.
Slough Sl1 4et
Berkshire, England,  GB
Correspondent Contact ABBOTT, PHD
Regulation Number866.3120
Classification Product Code
LJC  
Date Received05/28/1987
Decision Date 06/15/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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