Cleared Traditional

RAICHEM(TM) SPIA(TM) MICROALBULMIN REAGENT

K903123 · Reagents Applications, Inc. · Chemistry

Sep 1990

Decision

60d

Days

Class 1

Risk

About This 510(k) Submission

K903123 is an FDA 510(k) clearance for the RAICHEM(TM) SPIA(TM) MICROALBULMIN REAGENT, a Turbidimetric Method, Protein Or Albumin (urinary, Non-quant.) (Class I — General Controls, product code JIQ), submitted by Reagents Applications, Inc. (San Diego, US). The FDA issued a Cleared decision on September 14, 1990, 60 days after receiving the submission on July 16, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1645.

Submission Details

510(k) Number	K903123 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 16, 1990
Decision Date	September 14, 1990
Days to Decision	60 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—

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