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Code of Federal Regulations (Last Updated: July 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 862 - Clinical Chemistry and Clinical Toxicology Devices |
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Subpart C - Clinical Laboratory Instruments |
§ 862.2310 - Clinical sample concentrator.
Latest version.
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§ 862.2310 Clinical sample concentrator.
(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]