Section 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 .45 FR 60605, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989; 66 FR 38790 , July 25, 2001