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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name enzymatic method, ammonia
510(k) Number K030873
Device Name RANDOX AMMONIA
Applicant
RANDOX LABORATORIES, LTD.
55 DIAMOND RD.
CRUMLIN, COUNTY ANTRIM,  GB BT29 4QY
Applicant Contact LYNNE HAMILTON
Correspondent
RANDOX LABORATORIES, LTD.
55 DIAMOND RD.
CRUMLIN, COUNTY ANTRIM,  GB BT29 4QY
Correspondent Contact LYNNE HAMILTON
Regulation Number862.1065
Classification Product Code
JIF  
Date Received03/20/2003
Decision Date 05/12/2003
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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