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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Primary
510(k) Number K022682
Device Name RANDOX C-REACTIVE PROTEIN CALIBRATOR
Applicant
Randox Laboratories, Ltd.
55 Diamond Rd.
Crumlin,  GB BT29 4QY
Applicant Contact PAULINE ARMSTRONG
Correspondent
Randox Laboratories, Ltd.
55 Diamond Rd.
Crumlin,  GB BT29 4QY
Correspondent Contact PAULINE ARMSTRONG
Regulation Number862.1150
Classification Product Code
JIS  
Date Received08/12/2002
Decision Date 11/05/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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