Product Code: LAW
FDA class 1
21 CFR 862.3280
Theophylline Control Materials
Clinical Toxicology
Theophylline control materials are reference standards used in clinical toxicology laboratories to verify the accuracy and precision of theophylline assay systems, which measure blood levels of the bronchodilator theophylline. The device is classified as FDA Class 1, meaning it presents the lowest level of risk and requires only general regulatory controls without premarket notification. The product code is LAW, regulated under 21 CFR 862.3280, in the Clinical Toxicology specialty. No special flags apply.
510(k)s
4
FEI Numbers
0
Registration Numbers
0
Unique Applicants
4
Years Active
5
Basic Information
- Product Code
- LAW
- Device Class
- FDA class 1
- Regulation Number
- 862.3280
- Medical Specialty
- Clinical Toxicology
- Review Panel
- TX
- Submission Type
- 4
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
Loading...
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K920223 | CHEM CHEX THEOPHYLLINE CONTROL | Jun 10, 1992 | Substantially Equivalent | Streck Laboratories, Inc. |
| K914251 | MODEL IRC PASSPORT NEBULIZER | Jan 24, 1992 | Substantially Equivalent | Invacare Corp. |
| K903924 | BIOTRACK THEOPHYLLINE QUALITY CONTROLS | Sep 17, 1990 | Substantially Equivalent | Biotrack, Inc. |
| K871589 | THEOPHYLLINE FPIA CONTROLS | Jun 17, 1987 | Substantially Equivalent | Sigma Chemical Co. |