Cleared Traditional

GLYCOHEMOSURE HBA1C CONTROL

K032791 · Quantimetrix Corp. · Chemistry
Oct 2003
Decision
52d
Days
Class 2
Risk

About This 510(k) Submission

K032791 is an FDA 510(k) clearance for the GLYCOHEMOSURE HBA1C CONTROL, a Control, Hemoglobin (Class II — Special Controls, product code GGM), submitted by Quantimetrix Corp. (Redondo, US). The FDA issued a Cleared decision on October 30, 2003, 52 days after receiving the submission on September 8, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K032791 FDA.gov
FDA Decision Cleared SESE
Date Received September 08, 2003
Decision Date October 30, 2003
Days to Decision 52 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code GGM — Control, Hemoglobin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.8625

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