21 C.F.R. § 862.2310 Clinical sample concentrator.
Title 21 - Food and Drugs
(a) Identification. A clinical sample concentrator is a device intended to concentrate (by dialysis, evaporation, etc.) serum, urine, cerebrospinal fluid, and other body fluids before the fluids are analyzed. (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 the limitations in §862.9. [52 FR 16122, May 1, 1987, as amended at 60 FR 38899, July 28, 1995; 66 FR 38788, July 25, 2001]
Title 21: Food and Drugs
PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
Subpart C—Clinical Laboratory Instruments
§ 862.2310 Clinical sample concentrator.
