• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

  • Print
  • Share
  • E-mail
-

The information on this page is current as of Aug 30, 2024.

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

New Search
Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[CITE: 21CFR864.9575]
See Related Information on Environmental chamber for storage of platelet concentrate. 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 J - Products Used In Establishments That Manufacture Blood and Blood Products

Sec. 864.9575 Environmental chamber for storage of platelet concentrate.

(a) Identification. An environmental chamber for storage of platelet concentrate is a device used to hold platelet-rich plasma within a preselected temperature range.

(b) Classification. Class II (special 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 60648, Sept. 12, 1980, as amended at 63 FR 59226, Nov. 3, 1998]

-
-