Atlas FDA

NAQ

2 FDA 510(k) clearances · Product code

FDA profile

Official device name
Lipoprotein, High Density, Hdl, Over The Counter
Device class
Class I (low risk)
Regulation
21 CFR 862.1175
Medical specialty
Clinical Chemistry
Flags
Third-party review eligible
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
PTS PANELS HDL CHOLESTEROL TEST STRIPS (K060617)Polymer Technology Systems, Inc.2006-04-05
MTM BIOSCANNER HDL TEST STRIPS, OVER THE COUNTER (OTC) (K993377)Polymer Technology Systems, Inc.2000-01-13

Track NAQ automatically

Every clearance here is in the API, with alerts when new ones post.