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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Diphenylhydantoin
510(k) Number K011393
Device Name RANDOX PHENYTOIN
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 Number862.3350
Classification Product Code
DIP  
Date Received05/07/2001
Decision Date 12/04/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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