AUSAM TOTAL ALBUMIN ASSAY— 510(k) K013643

Name: FDA 510(k) clearance K013643
Creator: U.S. Food and Drug Administration
Published: 2003-08-14

Substantially Equivalent

Ausam Biotecthnologies, Inc.

FDA 510(k) clearance K013643 for AUSAM TOTAL ALBUMIN ASSAY, Substantially Equivalent on 2003-08-14. Applicant: Ausam Biotecthnologies, Inc.. Device class: 1.

Clearance details

Applicant: Ausam Biotecthnologies, Inc.
Product code: Code JIQ
Device class: Class 1
Regulation: 21 CFR 862.1645
Advisory panel: Clinical Chemistry
Date received: 2001-11-05
Decision date: 2003-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

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