K060617 is an FDA 510(k) clearance for the PTS PANELS HDL CHOLESTEROL TEST STRIPS. This device is classified as a Lipoprotein, High Density, Hdl, Over The Counter (Class I - General Controls, product code NAQ).
Submitted by Polymer Technology Systems, Inc. (Indianapolis, US). The FDA issued a Cleared decision on April 5, 2006, 28 days after receiving the submission on March 8, 2006.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1175.
| 510(k) Number | K060617 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 08, 2006 |
| Decision Date | April 05, 2006 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | NAQ - Lipoprotein, High Density, Hdl, Over The Counter |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1175 |