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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name multi-analyte controls, all kinds (assayed)
510(k) Number K972608
Device Name RANDOX ASSAYED SPECIFIC PROTEIN CONTROL
Applicant
RANDOX LABORATORIES, LTD.
ARDMORE, DIAMOND ROAD
CRUMLIN,  IE BT29 4QY
Applicant Contact P. ARMSTRONG
Correspondent
RANDOX LABORATORIES, LTD.
ARDMORE, DIAMOND ROAD
CRUMLIN,  IE BT29 4QY
Correspondent Contact P. ARMSTRONG
Regulation Number862.1660
Classification Product Code
JJY  
Date Received06/11/1997
Decision Date 08/04/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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