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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 K942458
Device Name PRECISION-MULTI-SERA - HUMAN - NORMAL AND ELEVATED
Applicant
RANDOX LABORATORIES, LTD.
ARDMORE, DIAMOND ROAD
CRUMLIN,  IE BT29 4QY
Applicant Contact John Lamont
Correspondent
RANDOX LABORATORIES, LTD.
ARDMORE, DIAMOND ROAD
CRUMLIN,  IE BT29 4QY
Correspondent Contact John Lamont
Regulation Number862.1660
Classification Product Code
JJY  
Date Received05/24/1994
Decision Date 03/13/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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