862.1385—17-Hydroxycorticosteroids (17-ketogenic steroids) test system.
(a) Identification.
A 17-hydroxycorticosteroids (17-ketogenic steroids) test system is a device intended to measure corticosteroids that possess a dihydroxyacetone
Code of Federal Regulations
Code of Federal Regulations
Code of Federal Regulations
203
(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 § 862.9.