FDA Product Code
FDA Product Code NAQ — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1175
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K060617 | PTS PANELS HDL CHOLESTEROL TEST STRIPS | Polymer Technology Systems, Inc. | 2006-04-05 | Special | PDF ↗ |
| K993377 | MTM BIOSCANNER HDL TEST STRIPS, OVER THE COUNTER (OTC) | Polymer Technology Systems, Inc. | 2000-01-13 | Traditional | PDF ↗ |
Product code NAQ · Class I · Clinical Chemistry. Data: openFDA.