21 CFR § 862.1575
Phospholipid test system
June 25, 2020
(a) Identification. A phospholipid test system is a device intended to measure phospholipids in serum and plasma. Measurements of phospholipids are used in the diagnosis and treatment of disorders involving lipid (fat) metabolism.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §862.9.
[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 FR 38788, July 25, 2001]
Tried the LawStack mobile app?
Join thousands and try LawStack mobile for FREE today.
- Carry the law offline, wherever you go.
- Download CFR, USC, rules, and state law to your mobile device.
