Cleared Special

D-10 HEMOGLOBIN A1C PROGRAM; D-10 DUAL PROGRAM

K060001 · Bio-Rad Laboratories, Inc. · Chemistry
Jan 2006
Decision
17d
Days
Class 2
Risk

About This 510(k) Submission

K060001 is an FDA 510(k) clearance for the D-10 HEMOGLOBIN A1C PROGRAM; D-10 DUAL PROGRAM, 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 January 20, 2006, 17 days after receiving the submission on January 3, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.7470.

Submission Details

510(k) Number K060001 FDA.gov
FDA Decision Cleared SESE
Date Received January 03, 2006
Decision Date January 20, 2006
Days to Decision 17 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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