LAZ · N-Acetylprocainamide Control Materials
Clinical Toxicology · 21 CFR 862.3280 · Class 1
Overview
| Product Code | LAZ |
|---|---|
| Device Name | N-Acetylprocainamide 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 (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K211667 | Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile) | Changzhou Universal Medical Equipment Co., Ltd. | Sep 23, 2021 | SESE |
| K851474 | VYGON SPINAL ANESTHESIA TRAY CODE NO. 190 | Vygon Corp. | May 7, 1985 | SESE |
| K823127 | ADVANCE EMIT-CAD PROCAINAMIDE/N-ACETYL | Syva Co. | Nov 29, 1982 | SESE |
| K811461 | EMIT-AND METHOTREXATE CONTROL | Syva Co. | Jun 9, 1981 | SESE |
Top Applicants
- Syva Co. — 2 clearances
- Changzhou Universal Medical Equipment Co., Ltd. — 1 clearance
- Vygon Corp. — 1 clearance
