21 C.F.R. § 864.6150 Capillary blood collection tube.
Title 21 - Food and Drugs
(a) Identification. A capillary blood collection tube is a plain or heparinized glass tube of very small diameter used to collect blood by capillary action. (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 §864.9. [45 FR 60604, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989; 65 FR 2310, Jan. 14, 2000]
Title 21: Food and Drugs
PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
Subpart G—Manual Hematology Devices
§ 864.6150 Capillary blood collection tube.