Cleared Traditional

HEMOGLOBIN A1C REAGENT SET

K031539 · Pointe Scientific, Inc., · Chemistry
Aug 2003
Decision
82d
Days
Class 2
Risk

About This 510(k) Submission

K031539 is an FDA 510(k) clearance for the HEMOGLOBIN A1C REAGENT SET, a Assay, Glycosylated Hemoglobin (Class II — Special Controls, product code LCP), submitted by Pointe Scientific, Inc., (Lincoln Park, US). The FDA issued a Cleared decision on August 6, 2003, 82 days after receiving the submission on May 16, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.7470.

Submission Details

510(k) Number K031539 FDA.gov
FDA Decision Cleared SESE
Date Received May 16, 2003
Decision Date August 06, 2003
Days to Decision 82 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code LCP — Assay, Glycosylated Hemoglobin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7470

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