Cleared Traditional

K000586: BIOSCANNER TRIGLYCERIDES TEST STRIPS

K000586 · Polymer Technology Systems, Inc. · Chemistry

Jul 2000

Decision

132d

Days

Class 1

Risk

K000586 is an FDA 510(k) clearance for the BIOSCANNER TRIGLYCERIDES TEST STRIPS, a Colorimetric Method, Triglycerides (Class I — General Controls, product code JGY), submitted by Polymer Technology Systems, Inc. (Indianapolis, US). The FDA issued a Cleared decision on July 3, 2000, 132 days after receiving the submission on February 22, 2000. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1705.

Submission Details

510(k) Number	K000586 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 22, 2000
Decision Date	July 03, 2000
Days to Decision	132 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF