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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 K013643
Device Name AUSAM TOTAL ALBUMIN ASSAY
Applicant
AUSAM BIOTECTHNOLOGIES INC
50 ROCKEFELLER PLAZA
NEW YORK,  NY  10020
Applicant Contact LYNN ROLAND
Correspondent
AUSAM BIOTECTHNOLOGIES INC
50 ROCKEFELLER PLAZA
NEW YORK,  NY  10020
Correspondent Contact LYNN ROLAND
Regulation Number862.1645
Classification Product Code
JIQ  
Date Received11/05/2001
Decision Date 08/14/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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