Cleared Traditional

DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID

K080618 · Jas Diagnostics, Inc. · Chemistry
May 2008
Decision
79d
Days
Class 2
Risk

About This 510(k) Submission

K080618 is an FDA 510(k) clearance for the DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID, a Assay, Glycosylated Hemoglobin (Class II — Special Controls, product code LCP), submitted by Jas Diagnostics, Inc. (Miami, US). The FDA issued a Cleared decision on May 23, 2008, 79 days after receiving the submission on March 5, 2008. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.7470.

Submission Details

510(k) Number K080618 FDA.gov
FDA Decision Cleared SESE
Date Received March 05, 2008
Decision Date May 23, 2008
Days to Decision 79 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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