21 CFR 864.6600 - Osmotic fragility test.

§ 864.6600 Osmotic fragility test.
(a) Identification. An osmotic fragility test is a device used to determine the resistance of red blood cells to hemolysis (destruction) in varying concentrations of hypotonic saline solutions.
(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 60607, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989; 66 FR 38790, July 25, 2001]

Title 21 published on 2013-04-01

no entries appear in the Federal Register after this date.

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.


United States Code