PTS PANELS LIPID PANEL TEST STRIPS— 510(k) K023558

Clearance details

Applicant

Polymer Technology Systems, Inc.

Product code

Code CHH

Device class

Class 1

Regulation

21 CFR 862.1175

Advisory panel

Clinical Chemistry

Date received

2002-10-23

Decision date

2002-11-15

Decision

Substantially Equivalent

Clearance type

Special

Location

Indianapolis, IN, US

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K023558.