Cleared Special

TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM

K072714 · Roche Diagnostics Corp. · Chemistry
Apr 2008
Decision
206d
Days
Class 2
Risk

About This 510(k) Submission

K072714 is an FDA 510(k) clearance for the TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM, a Assay, Glycosylated Hemoglobin (Class II — Special Controls, product code LCP), submitted by Roche Diagnostics Corp. (Indianapolos, US). The FDA issued a Cleared decision on April 18, 2008, 206 days after receiving the submission on September 25, 2007. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.7470.

Submission Details

510(k) Number K072714 FDA.gov
FDA Decision Cleared SESE
Date Received September 25, 2007
Decision Date April 18, 2008
Days to Decision 206 days
Submission Type Special
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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