View all text of Subpart G [§ 864.6100 - § 864.6700]
§ 864.6160 - Manual blood cell counting device.
(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.