Clinical sample concentrator.

21 C.F.R. § 862.2310
in effectEffective: 2024-07-01
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(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.

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