Cleared Traditional

EQUATE(TM) AQR APO AL/B DUO CONTROL

K903122 · Binax, Inc. · Immunology
Aug 1990
Decision
17d
Days
Class 2
Risk

About This 510(k) Submission

K903122 is an FDA 510(k) clearance for the EQUATE(TM) AQR APO AL/B DUO CONTROL, a Lipoprotein, Low-density, Antigen, Antiserum, Control (Class II — Special Controls, product code DFC), submitted by Binax, Inc. (S. Portland, US). The FDA issued a Cleared decision on August 2, 1990, 17 days after receiving the submission on July 16, 1990. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5600.

Submission Details

510(k) Number K903122 FDA.gov
FDA Decision Cleared SESE
Date Received July 16, 1990
Decision Date August 02, 1990
Days to Decision 17 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code DFC — Lipoprotein, Low-density, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5600

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