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Electronic Code of Federal Regulations

e-CFR data is current as of June 2, 2020

Title 21Chapter ISubchapter HPart 864Subpart J → §864.9700


Title 21: Food and Drugs
PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
Subpart J—Products Used In Establishments That Manufacture Blood and Blood Products


§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]

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