Cleared Traditional

RAICHEM SPIA C3 REAGENT

K911900 · Reagents Applications, Inc. · Immunology
May 1991
Decision
13d
Days
Class 2
Risk

About This 510(k) Submission

K911900 is an FDA 510(k) clearance for the RAICHEM SPIA C3 REAGENT, a Complement C3, Antigen, Antiserum, Control (Class II — Special Controls, product code CZW), submitted by Reagents Applications, Inc. (San Diego, US). The FDA issued a Cleared decision on May 9, 1991, 13 days after receiving the submission on April 26, 1991. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5240.

Submission Details

510(k) Number K911900 FDA.gov
FDA Decision Cleared SESE
Date Received April 26, 1991
Decision Date May 09, 1991
Days to Decision 13 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code CZW — Complement C3, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5240

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