21 C.F.R. § 864.6160 Manual blood cell counting device.
Title 21 - Food and Drugs
(a) Identification. A manual blood cell counting device is a device used to count red blood cells, white blood cells, or blood platelets. (b) Classification. Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §864.9. [45 FR 60605, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989; 66 FR 38790, July 25, 2001]
Title 21: Food and Drugs
PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
Subpart G—Manual Hematology Devices
§ 864.6160 Manual blood cell counting device.
