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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, Iron (Non-Heme)
510(k) Number K020816
Device Name IRON-PC-SL ASSAY MODEL # 151-10, 151-26
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 Number862.1410
Classification Product Code
JIY  
Date Received03/13/2002
Decision Date 05/14/2002
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
Predetermined Change
Control Plan Authorized		 No
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