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Electronic Code of Federal Regulations

e-CFR data is current as of October 10, 2019

Title 21Chapter ISubchapter HPart 864Subpart G → §864.6160


Title 21: Food and Drugs
PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
Subpart G—Manual Hematology Devices


§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]

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