Cleared Special

A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC

K090413 · Bayer Healthcare, LLC · Chemistry
May 2009
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K090413 is an FDA 510(k) clearance for the A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC, a Assay, Glycosylated Hemoglobin (Class II — Special Controls, product code LCP), submitted by Bayer Healthcare, LLC (Sunnyvale, US). The FDA issued a Cleared decision on May 14, 2009, 85 days after receiving the submission on February 18, 2009. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.7470.

Submission Details

510(k) Number K090413 FDA.gov
FDA Decision Cleared SESE
Date Received February 18, 2009
Decision Date May 14, 2009
Days to Decision 85 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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