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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 K895280
Device Name CLEARVIEW CHLAMYDIA
Applicant
Unipath , Ltd.
Norse Rd.
Bedford Mk41 Oqg,  GB
Applicant Contact G. T ZAJICEK
Correspondent
Unipath , Ltd.
Norse Rd.
Bedford Mk41 Oqg,  GB
Correspondent Contact G. T ZAJICEK
Regulation Number866.3120
Classification Product Code
LJC  
Date Received08/24/1989
Decision Date 01/29/1990
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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