LAW · Theophylline Control Materials
Clinical Toxicology · 21 CFR 862.3280 · Class 1
Overview
| Product Code | LAW |
|---|---|
| Device Name | Theophylline 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 |
|---|---|---|---|---|
| K920223 | CHEM CHEX THEOPHYLLINE CONTROL | Streck Laboratories, Inc. | Jun 10, 1992 | SESE |
| K914251 | MODEL IRC PASSPORT NEBULIZER | Invacare Corp. | Jan 24, 1992 | SESE |
| K903924 | BIOTRACK THEOPHYLLINE QUALITY CONTROLS | Biotrack, Inc. | Sep 17, 1990 | SESE |
| K871589 | THEOPHYLLINE FPIA CONTROLS | Sigma Chemical Co. | Jun 17, 1987 | SESE |
Top Applicants
- Biotrack, Inc. — 1 clearance
- Invacare Corp. — 1 clearance
- Sigma Chemical Co. — 1 clearance
- Streck Laboratories, Inc. — 1 clearance
