Cleared Traditional

BINAXNOW G6PD TEST

K080003 · Binax, Inc. · Hematology
Oct 2008
Decision
295d
Days
Class 2
Risk

About This 510(k) Submission

K080003 is an FDA 510(k) clearance for the BINAXNOW G6PD TEST, a Glucose-6-phosphate Dehydrogenase (erythrocytic), Screening (Class II — Special Controls, product code JBF), submitted by Binax, Inc. (Scarborough, US). The FDA issued a Cleared decision on October 23, 2008, 295 days after receiving the submission on January 2, 2008. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7360.

Submission Details

510(k) Number K080003 FDA.gov
FDA Decision Cleared SESE
Date Received January 02, 2008
Decision Date October 23, 2008
Days to Decision 295 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code JBF — Glucose-6-phosphate Dehydrogenase (erythrocytic), Screening
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7360