Cleared Special

A1CNOW FOR PROFESSIONAL USE

K020235 · Metrika, Inc. · Hematology
Feb 2002
Decision
23d
Days
Class 2
Risk

About This 510(k) Submission

K020235 is an FDA 510(k) clearance for the A1CNOW FOR PROFESSIONAL USE, a Assay, Glycosylated Hemoglobin (Class II — Special Controls, product code LCP), submitted by Metrika, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on February 15, 2002, 23 days after receiving the submission on January 23, 2002. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7470.

Submission Details

510(k) Number K020235 FDA.gov
FDA Decision Cleared SESE
Date Received January 23, 2002
Decision Date February 15, 2002
Days to Decision 23 days
Submission Type Special
Review Panel Hematology (HE)
Summary Statement

Device Classification

Product Code LCP — Assay, Glycosylated Hemoglobin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7470

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