510(k) K060617
- Device
- PTS PANELS HDL CHOLESTEROL TEST STRIPS
- Applicant
- POLYMER TECHNOLOGY SYSTEMS, INC.
- 510(k) number
- K060617
- Product code
- NAQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-04-05
- Date received
- 2006-03-08
- Regulation
- 862.1175
- Classification name
- Lipoprotein, High Density, Hdl, Over The Counter
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARGO ENRIGHT
- Address
- 7736 Zionsville Rd. Indianapolis IN US 46268 46268
FDA Registration Numbers#
- 3015525148
- 3021841051
Source Documents#
Other 510(k) Records For Product Code NAQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K993377 | MTM BIOSCANNER HDL TEST STRIPS, OVER THE COUNTER (OTC) | Polymer Technology Systems, Inc. | 2000-01-13 |
Legacy Summary#
summary
FDA Review#
Decision Summary