Cleared Traditional

K182781 - PTS Professional Chemistry Kit (FDA 510(k) Clearance)

K182781 · Polymer Technology Systems, Inc. D/B/A Pts Diagnostics · Chemistry device

Dec 2018

Decision

81d

Days

Class 2

Risk

K182781 is an FDA 510(k) clearance for the PTS Professional Chemistry Kit. This device is classified as a Glucose Oxidase, Glucose (Class II - Special Controls, product code CGA).

Submitted by Polymer Technology Systems, Inc. D/B/A Pts Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on December 21, 2018, 81 days after receiving the submission on October 1, 2018.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number	K182781 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received	October 01, 2018
Decision Date	December 21, 2018
Days to Decision	81 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF