21 CFR 862.2680 — Microtitrator, For Clinical Use
Clinical Chemistry (CH) · Part 862 Subpart C—Clinical Laboratory Instruments · § 862.2680
Identification
A microtitrator for clinical use is a device intended for use in micronanalysis to measure the concentration of a substance by reacting it with a measure “micro” volume of a known standardized solution.
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 § 862.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| JRA | Microtitrator, For Clinical Use | 1 | 1 |
