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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name photometric method, magnesium
510(k) Number K974606
Device Name RANDOX MAGNESIUM
Applicant
RANDOX LABORATORIES, LTD.
55 DIAMOND RD.
CRUMLIN, CO. ANTRIM,  IE BT29 4QY
Applicant Contact P. ARMSTRONG
Correspondent
RANDOX LABORATORIES, LTD.
55 DIAMOND RD.
CRUMLIN, CO. ANTRIM,  IE BT29 4QY
Correspondent Contact P. ARMSTRONG
Regulation Number862.1495
Classification Product Code
JGJ  
Date Received12/10/1997
Decision Date 02/12/1998
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
Recalls CDRH Recalls
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