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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alkaline Picrate, Colorimetry, Creatinine
510(k) Number K000055
Device Name CREATININE-S ASSAY, MODEL 221-30, 221-50, 221-17
Applicant
DIAGNOSTIC CHEMICALS LTD.
16 MCCARVILLE ST.
CHARLOTTETOWN,  CA C1E 2A6
Applicant Contact KAREN CALLBECK
Correspondent
DIAGNOSTIC CHEMICALS LTD.
16 MCCARVILLE ST.
CHARLOTTETOWN,  CA C1E 2A6
Correspondent Contact KAREN CALLBECK
Regulation Number862.1225
Classification Product Code
CGX  
Date Received01/07/2000
Decision Date 02/18/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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