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Code · CFR · Title 21 — Food and Drugs · Part 862 — Clinical Chemistry and Clinical Toxicology Devices · § 862.2100

§ 862.2100. Calculator/data processing module for clinical use.

76 words·~1 min read·/us/cfr/t21/s§ 862.2100·

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(a)Identification. A calculator/data processing module for clinical use is an electronic device intended to process laboratory data.
(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 53 FR 21449, June 8, 1988; 66 FR 38788, July 25, 2001; 86 FR 20283, Apr. 19, 2021]
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§ 862.2100
Calculator/data processing module for clinical use.
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