Cleared Traditional

K020532 - POLYMEDCO HBA1C TEST
(FDA 510(k) Clearance)

K020532 · Polymedco, Inc. · Hematology

Apr 2002

Decision

64d

Days

Class 2

Risk

K020532 is an FDA 510(k) clearance for the POLYMEDCO HBA1C TEST, 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 April 24, 2002, 64 days after receiving the submission on February 19, 2002. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7470.

Submission Details

510(k) Number	K020532 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 19, 2002
Decision Date	April 24, 2002
Days to Decision	64 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Statement