Electronic Code of Federal Regulations
We invite you to try out our new beta eCFR site at
https://ecfr.federalregister.gov. We have made big
changes to make the eCFR easier to use. Be sure to leave feedback using the Feedback button on the bottom
right of each page!
|
e-CFR data is current as of April 8, 2021 |
Title 21 → Chapter I → Subchapter H → Part 862 → Subpart C → §862.2100 |
Title 21: Food and Drugs
PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
Subpart C—Clinical Laboratory Instruments
§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 store, retrieve, and 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]