Cleared Traditional

LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4

K052838 · Bio-Rad · Chemistry
Nov 2005
Decision
33d
Days
Class 2
Risk

About This 510(k) Submission

K052838 is an FDA 510(k) clearance for the LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4, a Control, Hemoglobin (Class II — Special Controls, product code GGM), submitted by Bio-Rad (Irvine, US). The FDA issued a Cleared decision on November 9, 2005, 33 days after receiving the submission on October 7, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K052838 FDA.gov
FDA Decision Cleared SESE
Date Received October 07, 2005
Decision Date November 09, 2005
Days to Decision 33 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code GGM — Control, Hemoglobin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.8625

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