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510(k) K013643

AUSAM TOTAL ALBUMIN ASSAY by Ausam Biotecthnologies, Inc. — Product Code JIQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 2003
Date Received
November 5, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)
Device Class
Class I
Regulation Number
862.1645
Review Panel
CH
Submission Type

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