Cleared Traditional

RAICHEM(TM) SPIA(TM) IGM REAGENTS

K894417 · Reagents Applications, Inc. · Chemistry
Aug 1989
Decision
16d
Days
Class 2
Risk

About This 510(k) Submission

K894417 is an FDA 510(k) clearance for the RAICHEM(TM) SPIA(TM) IGM REAGENTS, a Igm, Antigen, Antiserum, Control (Class II — Special Controls, product code DFT), submitted by Reagents Applications, Inc. (San Diego, US). The FDA issued a Cleared decision on August 2, 1989, 16 days after receiving the submission on July 17, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.5550.

Submission Details

510(k) Number K894417 FDA.gov
FDA Decision Cleared SESE
Date Received July 17, 1989
Decision Date August 02, 1989
Days to Decision 16 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code DFT — Igm, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5550

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