Cleared Traditional

AUSAM TOTAL ALBUMIN ASSAY

K013643 · Ausam Biotecthnologies, Inc. · Chemistry

Aug 2003

Decision

647d

Days

Class 1

Risk

About This 510(k) Submission

K013643 is an FDA 510(k) clearance for the AUSAM TOTAL ALBUMIN ASSAY, a Turbidimetric Method, Protein Or Albumin (urinary, Non-quant.) (Class I — General Controls, product code JIQ), submitted by Ausam Biotecthnologies, Inc. (New York, US). The FDA issued a Cleared decision on August 14, 2003, 647 days after receiving the submission on November 5, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1645.

Submission Details

510(k) Number	K013643 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 05, 2001
Decision Date	August 14, 2003
Days to Decision	647 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement

Device Classification

Product Code	JIQ — Turbidimetric Method, Protein Or Albumin (urinary, Non-quant.)
Device Class	Class I — General Controls
CFR Regulation	21 CFR 862.1645