DMP · Digoxin Control Serum, Ria
Clinical Toxicology · 21 CFR 862.3280 · Class 1
Overview
| Product Code | DMP |
|---|---|
| Device Name | Digoxin Control Serum, Ria |
| 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 (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K973973 | ELECSYS CALLCHECK DIGOXIN | Boehringer Mannheim Corp. | Nov 4, 1997 | SESE |
| K953393 | TOX PERFECT A TUBE | Chimera Research & Chemical, Inc. | Oct 6, 1995 | SESE |
| K780889 | DIGOXIN STANDARDS IN HUMAN SERUM | Pcl-Ria, Inc. | Aug 14, 1978 | SESE |
| K770411 | DIGI TROL TM-RX & DIGI TROL TM-TX | Nuclear Medical Laboratories, Inc. | Mar 16, 1977 | SESE |
Top Applicants
- Boehringer Mannheim Corp. — 1 clearance
- Chimera Research & Chemical, Inc. — 1 clearance
- Nuclear Medical Laboratories, Inc. — 1 clearance
- Pcl-Ria, Inc. — 1 clearance
