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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Anticardiolipin Immunological
510(k) Number K021192
Device Name QACA IGG/IGM ELISA KIT HRP
Applicant
Cheshire Diagnostics , Ltd.
7 Elm St.
Ellesmere Port,  GB CH65 2AU
Applicant Contact NEIL B STRINGER
Correspondent
Cheshire Diagnostics , Ltd.
7 Elm St.
Ellesmere Port,  GB CH65 2AU
Correspondent Contact NEIL B STRINGER
Regulation Number866.5660
Classification Product Code
MID  
Date Received04/15/2002
Decision Date 05/16/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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