U.V. Spectrometry, Theophylline
UV spectrometry for theophylline measurement is a laboratory analytical method that uses ultraviolet light absorption to quantify theophylline concentrations in patient specimens, supporting therapeutic drug monitoring for patients with asthma or chronic obstructive pulmonary disease. It is classified as FDA Class 2, requiring 510(k) premarket clearance. The product code is LCY, regulated under 21 CFR 862.3880, in the Clinical Toxicology specialty. Third-party review is available.
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Basic Information
- Product Code
- LCY
- Device Class
- FDA class 2
- Regulation Number
- 862.3880
- Medical Specialty
- Clinical Toxicology
- Review Panel
- TX
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K891761 | GDS ENZYMATIC THEOPHYLLINE REAGENT | May 16, 1989 | Substantially Equivalent | Gds Diagnostics |
| K780442 | THEOPHYLLINE ASSAY TO THE GEMSAEC | Apr 12, 1978 | Substantially Equivalent | Syva Co. |
| K780441 | THEOPHYLLINE ASSAY TO THE CENTRIFICHEM | Apr 12, 1978 | Substantially Equivalent | Syva Co. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.