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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Primary
510(k) Number K936201
Device Name URINARY ALBUMIN CALIBRATOR
Applicant
Dupont Medical Products
331 Treble Cove Rd.
N. Billerica,  MA  01862
Applicant Contact REBECCA S AYASH
Correspondent
Dupont Medical Products
331 Treble Cove Rd.
N. Billerica,  MA  01862
Correspondent Contact REBECCA S AYASH
Regulation Number862.1150
Classification Product Code
JIS  
Date Received12/29/1993
Decision Date 03/11/1994
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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