Cleared Traditional

RAICHEM(TM) SPIA(TM) TRANSFERRIN REAGENT

K900875 · Reagents Applications, Inc. · Chemistry
Mar 1990
Decision
8d
Days
Class 2
Risk

About This 510(k) Submission

K900875 is an FDA 510(k) clearance for the RAICHEM(TM) SPIA(TM) TRANSFERRIN REAGENT, a Transferrin, Antigen, Antiserum, Control (Class II — Special Controls, product code DDG), submitted by Reagents Applications, Inc. (San Diego, US). The FDA issued a Cleared decision on March 6, 1990, 8 days after receiving the submission on February 26, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.5880.

Submission Details

510(k) Number K900875 FDA.gov
FDA Decision Cleared SESE
Date Received February 26, 1990
Decision Date March 06, 1990
Days to Decision 8 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code DDG — Transferrin, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5880

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