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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 K861094
Device Name BILIRUBIN ASSAY KIT (DIRECT), CATA. NUMBER 202-02
Original Applicant
DIAGNOSTIC CHEMICALS, LTD. (USA)
16 first st.
west royalty industrial park
charlottestown,pei,canada,  CA c1e 1b0
Original Contact callbeck, r.t.
Regulation Number862.1110
Classification Product Code
CIG  
Date Received03/24/1986
Decision Date 04/21/1986
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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