Cleared Traditional

K023654 - GLYCA-DIRECT FRUCTOSAMINE
(FDA 510(k) Clearance)

K023654 · Polymedco, Inc. · Chemistry

May 2003

Decision

184d

Days

Class 2

Risk

K023654 is an FDA 510(k) clearance for the GLYCA-DIRECT FRUCTOSAMINE, a Assay, Glycosylated Hemoglobin (Class II — Special Controls, product code LCP), submitted by Polymedco, Inc. (Cortlandt Manor, US). The FDA issued a Cleared decision on May 2, 2003, 184 days after receiving the submission on October 30, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.7470.

Submission Details

510(k) Number	K023654 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 30, 2002
Decision Date	May 02, 2003
Days to Decision	184 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement