LBA · Procainamide Control Materials
Clinical Toxicology · 21 CFR 862.3280 · Class 1
Overview
| Product Code | LBA |
|---|---|
| Device Name | Procainamide Control Materials |
| Regulation | 21 CFR 862.3280 |
| Device Class | Class 1 |
| Review Panel | Clinical Toxicology |
Identification
A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.
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.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K833227 | SONICAID MODEL D206E AIR EMBOLI-DETECT | Sonicaid, Inc. | Oct 27, 1983 | SESE |
Top Applicants
- Sonicaid, Inc. — 1 clearance
