Cleared Traditional

DREW SCIENTIFIC GLYCATED HEMOGLOBIN FIVE LEVEL LINEARITY KIT

K060510 · Drew Scientific , Ltd. · Chemistry
Jun 2006
Decision
112d
Days
Class 1
Risk

About This 510(k) Submission

K060510 is an FDA 510(k) clearance for the DREW SCIENTIFIC GLYCATED HEMOGLOBIN FIVE LEVEL LINEARITY KIT, a Single (specified) Analyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJX), submitted by Drew Scientific , Ltd. (Barrow In Furness Cumbria, GB). The FDA issued a Cleared decision on June 19, 2006, 112 days after receiving the submission on February 27, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K060510 FDA.gov
FDA Decision Cleared SESE
Date Received February 27, 2006
Decision Date June 19, 2006
Days to Decision 112 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JJX — Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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