21 CFR 862.2900 — Automated Urinalysis System
Clinical Chemistry (CH) · Part 862 Subpart C—Clinical Laboratory Instruments · § 862.2900
Identification
An automated urinalysis system is a device intended to measure certain of the physical properties and chemical constituents of urine by procedures that duplicate manual urinalysis systems. This device is used in conjunction with certain materials to measure a variety of urinary analytes.
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 |
|---|---|---|---|---|
| KQO | Automated Urinalysis System | 1 | 46 |
