21 CFR 864.9700 - Blood storage refrigerator and blood storage freezer.
(a) Identification. A blood storage refrigerator and a blood storage freezer are devices intended for medical purposes that are used to preserve blood and blood products by storing them at cold or freezing temperatures.
(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.
[45 FR 60650, Sept. 12, 1980, as amended at 63 FR 59226, Nov. 3, 1998]
Title 21 published on 2015-04-01.
No entries appear in the Federal Register after this date, for 21 CFR Part 864.