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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diazo Colorimetry, Bilirubin
510(k) Number K023330
Device Name BILIRUBIN-SL (TOTAL) ASSAY, MODEL 284-10/30
Applicant
Diagnostic Chemicals , Ltd.
16 Mccarville St.
Charlottetown, P.E.,  CA C1E 2A6
Applicant Contact NANCY OLSCAMP
Correspondent
Diagnostic Chemicals , Ltd.
16 Mccarville St.
Charlottetown, P.E.,  CA C1E 2A6
Correspondent Contact NANCY OLSCAMP
Regulation Number862.1110
Classification Product Code
CIG  
Date Received10/04/2002
Decision Date 12/11/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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