21 CFR 864.6160 - Manual blood cell counting device.

§ 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]

Title 21 published on 2014-04-01

no entries appear in the Federal Register after this date.

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