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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)
510(k) Number K021516
Device Name DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP 200
Applicant
Axis-Shield Diagnostics, Ltd.
The Technology Park
Luna Pl.
Dundee, Scotland,  GB DD2 1XA
Applicant Contact EILEEN MCCAFFERTY
Correspondent
Axis-Shield Diagnostics, Ltd.
The Technology Park
Luna Pl.
Dundee, Scotland,  GB DD2 1XA
Correspondent Contact EILEEN MCCAFFERTY
Regulation Number866.5775
Classification Product Code
NHX  
Date Received05/10/2002
Decision Date 07/23/2002
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
Recalls CDRH Recalls
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