Cleared Traditional

RAICHEM(TM) SPIA(TM) HAPTOGLOBIN REAGENT

K911898 · Reagents Applications, Inc. · Immunology
May 1991
Decision
12d
Days
Class 2
Risk

About This 510(k) Submission

K911898 is an FDA 510(k) clearance for the RAICHEM(TM) SPIA(TM) HAPTOGLOBIN REAGENT, a Haptoglobin, Antigen, Antiserum, Control (Class II — Special Controls, product code DAD), submitted by Reagents Applications, Inc. (San Diego, US). The FDA issued a Cleared decision on May 8, 1991, 12 days after receiving the submission on April 26, 1991. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5460.

Submission Details

510(k) Number K911898 FDA.gov
FDA Decision Cleared SESE
Date Received April 26, 1991
Decision Date May 08, 1991
Days to Decision 12 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code DAD — Haptoglobin, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5460

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