21 CFR 862.2860 — Mass Spectrometer, Clinical Use
Clinical Chemistry (CH) · Part 862 Subpart C—Clinical Laboratory Instruments · § 862.2860
Identification
A mass spectrometer for clinical use is a device intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens by ionizing the compound under investigation and separating the resulting ions by means of an electrical and magnetic field according to their mass.
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 |
|---|---|---|---|---|
| DOP | Mass Spectrometer, Clinical Use | 1 | 10 |
