Cleared Traditional

VARIANT II TURBO HBA1C KIT KIT-20 AND WASH/DILUENT SOLUTION SET, MODELS 270-2455, 270-2730

K090699 · Bio-Rad Laboratories, Inc. · Chemistry
Jul 2009
Decision
132d
Days
Class 2
Risk

About This 510(k) Submission

K090699 is an FDA 510(k) clearance for the VARIANT II TURBO HBA1C KIT KIT-20 AND WASH/DILUENT SOLUTION SET, MODELS 270-2455, 270-2730, a Assay, Glycosylated Hemoglobin (Class II — Special Controls, product code LCP), submitted by Bio-Rad Laboratories, Inc. (Hercules, US). The FDA issued a Cleared decision on July 27, 2009, 132 days after receiving the submission on March 17, 2009. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.7470.

Submission Details

510(k) Number K090699 FDA.gov
FDA Decision Cleared SESE
Date Received March 17, 2009
Decision Date July 27, 2009
Days to Decision 132 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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