Cleared Traditional

RAICHEM (TM) SPIA (TM) - ACID GLYCOPROTEIN REAGENT

K904175 · Reagents Applications, Inc. · Immunology
Nov 1990
Decision
63d
Days
Class 1
Risk

About This 510(k) Submission

K904175 is an FDA 510(k) clearance for the RAICHEM (TM) SPIA (TM) - ACID GLYCOPROTEIN REAGENT, a Alpha-1-acid-glycoprotein, Antigen, Antiserum, Control (Class I — General Controls, product code LKL), submitted by Reagents Applications, Inc. (San Diego, US). The FDA issued a Cleared decision on November 13, 1990, 63 days after receiving the submission on September 11, 1990. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5420.

Submission Details

510(k) Number K904175 FDA.gov
FDA Decision Cleared SESE
Date Received September 11, 1990
Decision Date November 13, 1990
Days to Decision 63 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code LKL — Alpha-1-acid-glycoprotein, Antigen, Antiserum, Control
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.5420

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