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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)
510(k) Number K936202
Device Name URINARY ALBUMIN TEST PACK
Applicant
Dupont Medical Products
P.O. Box 80022, Bmp 22-1174
Wilmington,  DE  19880
Applicant Contact REBECCA S AYASH
Correspondent
Dupont Medical Products
P.O. Box 80022, Bmp 22-1174
Wilmington,  DE  19880
Correspondent Contact REBECCA S AYASH
Regulation Number862.1645
Classification Product Code
JIQ  
Date Received12/29/1993
Decision Date 05/09/1994
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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