NAQ — Lipoprotein, High Density, Hdl, Over The Counter Class I

FDA Device Classification

FDA product code NAQ covers "Lipoprotein, High Density, Hdl, Over The Counter", a Class I medical device regulated under 21 CFR 862.1175. Submissions are reviewed by the Clinical Chemistry panel. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
NAQ
Device Class
Class I
Regulation Number
862.1175
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K060617polymer technology systemsPTS PANELS HDL CHOLESTEROL TEST STRIPSApril 5, 2006
K993377polymer technology systemsMTM BIOSCANNER HDL TEST STRIPS, OVER THE COUNTER (OTC)January 13, 2000