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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
510(k) Number K994035
Device Name IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15
Applicant
Diagnostic Chemicals , Ltd.
16 Mccarville St.
Charlottetown, P.E.,  CA C1E 2A6
Applicant Contact KAREN CALLBECK
Correspondent
Diagnostic Chemicals , Ltd.
16 Mccarville St.
Charlottetown, P.E.,  CA C1E 2A6
Correspondent Contact KAREN CALLBECK
Regulation Number862.1645
Classification Product Code
JIR  
Date Received11/29/1999
Decision Date 02/01/2000
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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