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CFR - Code of Federal Regulations Title 21

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[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2009]
[CITE: 21CFR864.5400]
 See Related Information on 864.5400 in CDRH databases



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. 864.5400 Coagulation instrument.

(a)Identification. A coagulation instrument is an automated or semiautomated device used to determine the onset of clot formation for in vitro coagulation studies.

(b)Classification. Class II (performance standards).

[45 FR 60598, Sept. 12, 1980]

 
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