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§ 862.2100 Calculator/data processing module for clinical use.

21 CFR 862.2100

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  3. Title 21
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  5. Chapter I
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  7. Part 862
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  9. Subpart C
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  11. 21 CFR 862.2100
Citation21 CFR 862.2100
CorpusDaily eCFR
Displayed edition2026-04-27
Last updated2026-04-27

§ 862.2100 Calculator/data processing module for clinical use.

(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]