§864.7290. Factor deficiency test. — Inbound Citations
21 C.F.R. § 864.7290
Statutory Authority
Cited by 1 regulation in release Current.
Citations to 21 C.F.R. § 864.7290 as a whole
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(b) Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9. This exemption does not apply to factor deficiency tests classified under § 864.7290 of this chapter.