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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 K880799
Device Name MODIFIED IDEIA CHLAMYDIA TEST
Applicant
Boots-Celltech Diagnostics, Inc.
Bldg. 300, Suite 200
I-94 At Highway 22
Lincolnshire,  IL  60015
Applicant Contact S WELLS
Correspondent
Boots-Celltech Diagnostics, Inc.
Bldg. 300, Suite 200
I-94 At Highway 22
Lincolnshire,  IL  60015
Correspondent Contact S WELLS
Regulation Number866.3120
Classification Product Code
LJC  
Date Received02/29/1988
Decision Date 12/08/1988
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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