Cleared Traditional

HBA1C ENZYMATIC ASSAY

K050178 · General Atomics · Chemistry
Jun 2005
Decision
153d
Days
Class 2
Risk

About This 510(k) Submission

K050178 is an FDA 510(k) clearance for the HBA1C ENZYMATIC ASSAY, a Assay, Glycosylated Hemoglobin (Class II — Special Controls, product code LCP), submitted by General Atomics (San Diego, US). The FDA issued a Cleared decision on June 28, 2005, 153 days after receiving the submission on January 26, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.7470.

Submission Details

510(k) Number K050178 FDA.gov
FDA Decision Cleared SESE
Date Received January 26, 2005
Decision Date June 28, 2005
Days to Decision 153 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

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

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