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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 K033921
Device Name AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10
Applicant
DIAGNOSTIC CHEMICALS LTD.
16 MCCARVILLE ST.
CHARLOTTETOWN,  CA C1E 2A6
Applicant Contact NANCY OLSCAMP
Correspondent
DIAGNOSTIC CHEMICALS LTD.
16 MCCARVILLE ST.
CHARLOTTETOWN,  CA C1E 2A6
Correspondent Contact NANCY OLSCAMP
Regulation Number862.1065
Classification Product Code
JIF  
Date Received12/18/2003
Decision Date 03/10/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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