Cleared Traditional

URINARY ALBUMIN TEST PACK

K936202 · Dupont Medical Products · Chemistry

May 1994

Decision

131d

Days

Class 1

Risk

About This 510(k) Submission

K936202 is an FDA 510(k) clearance for the URINARY ALBUMIN TEST PACK, a Turbidimetric Method, Protein Or Albumin (urinary, Non-quant.) (Class I — General Controls, product code JIQ), submitted by Dupont Medical Products (Wilmington, US). The FDA issued a Cleared decision on May 9, 1994, 131 days after receiving the submission on December 29, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1645.

Submission Details

510(k) Number	K936202 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 29, 1993
Decision Date	May 09, 1994
Days to Decision	131 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF

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