Cleared Traditional

IMMAGE IMMUNOCHEMISTRY SYSTEM MICROALBUMIN (MA) REAGENT

K965035 · Beckman Instruments, Inc. · Immunology

Apr 1997

Decision

121d

Days

Class 1

Risk

About This 510(k) Submission

K965035 is an FDA 510(k) clearance for the IMMAGE IMMUNOCHEMISTRY SYSTEM MICROALBUMIN (MA) REAGENT, a Turbidimetric Method, Protein Or Albumin (urinary, Non-quant.) (Class I — General Controls, product code JIQ), submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on April 17, 1997, 121 days after receiving the submission on December 17, 1996. This device falls under the Immunology review panel. Regulated under 21 CFR 862.1645.

Submission Details

510(k) Number	K965035 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 17, 1996
Decision Date	April 17, 1997
Days to Decision	121 days
Submission Type	Traditional
Review Panel	Immunology (IM)
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