PTS PANELS HDL CHOLESTEROL TEST STRIPS

Lipoprotein, High Density, Hdl, Over The Counter

POLYMER TECHNOLOGY SYSTEMS, INC.

The following data is part of a premarket notification filed by Polymer Technology Systems, Inc. with the FDA for Pts Panels Hdl Cholesterol Test Strips.

Pre-market Notification Details

• Device ID: K060617
• 510k Number: K060617
• Device Name: PTS PANELS HDL CHOLESTEROL TEST STRIPS
• Classification: Lipoprotein, High Density, Hdl, Over The Counter
• Applicant: POLYMER TECHNOLOGY SYSTEMS, INC. 7736 ZIONSVILLE RD. Indianapolis, IN 46268
• Contact: Margo Enright
• Correspondent: Margo Enright; POLYMER TECHNOLOGY SYSTEMS, INC. 7736 ZIONSVILLE RD. Indianapolis, IN 46268
• Product Code: NAQ
• CFR Regulation Number: 862.1175 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-03-08
• Decision Date: 2006-04-05
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00381931788015	K060617	000
00381931714014	K060617	000