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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Specimen Collection
510(k) Number K862607
Device Name IMAGEN(TM) CHLAMYDIA SPECIMEN COLLECTION KIT
Applicant
Boots-Celltech Diagnostics, Inc.
240 Bath Rd.
Slough Sl1 4et
Berkshire, England,  GB
Applicant Contact JOHN G SIMPSON
Correspondent
Boots-Celltech Diagnostics, Inc.
240 Bath Rd.
Slough Sl1 4et
Berkshire, England,  GB
Correspondent Contact JOHN G SIMPSON
Regulation Number866.2900
Classification Product Code
LIO  
Date Received07/08/1986
Decision Date 08/04/1986
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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