21 CFR 862.2100 — Calculator/Data Processing Module, For Clinical Use
Clinical Chemistry (CH) · Part 862 Subpart C—Clinical Laboratory Instruments · § 862.2100
Identification
A calculator/data processing module for clinical use is an electronic device intended to process laboratory data.
Classification Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| JQP | Calculator/Data Processing Module, For Clinical Use | 1 | 78 | |
| NVV | Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System | 1 | 0 | SaMD |
