CFR
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862.1575—Phospholipid test system.
(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.
Code of Federal Regulations
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