Cleared Special

VARIANT II TURBO HEMOGLOBIN A1C PROGRAM, HEMOGLOBIN TESTING SYSTEM WITH CDM 4.0

K063400 · Bio-Rad Laboratories, Inc. · Chemistry
Dec 2006
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K063400 is an FDA 510(k) clearance for the VARIANT II TURBO HEMOGLOBIN A1C PROGRAM, HEMOGLOBIN TESTING SYSTEM WITH CDM 4.0, 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 December 1, 2006, 22 days after receiving the submission on November 9, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.7470.

Submission Details

510(k) Number K063400 FDA.gov
FDA Decision Cleared SESE
Date Received November 09, 2006
Decision Date December 01, 2006
Days to Decision 22 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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