CFR - Code of Federal Regulations Title 21

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For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 8]

[CITE: 21CFR864.5240]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER H - MEDICAL DEVICES

PART 864 -- HEMATOLOGY AND PATHOLOGY DEVICES

Subpart F - Automated and Semi-Automated Hematology Devices

Sec. 864.5240 Automated blood cell diluting apparatus.

(a) Identification. An automated blood cell diluting apparatus is a fully automated or semi-automated device used to make appropriate dilutions of a blood sample for further testing.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.

[45 FR 60596, Sept. 12, 1980, as amended at 65 FR 2310, Jan. 14, 2000]