FDA product code LCY: U.V. Spectrometry, Theophylline
LCY is the FDA product code for u.v. spectrometry, theophylline. It is a Class II device, regulated under 21 CFR 862.3880 and reviewed by the Clinical Toxicology panel. FDA has cleared 3 510(k) submissions under LCY, from 2 different applicants. The average 510(k) review took 33 days (median 23).
Classification
| Field | Value |
|---|---|
| Device name | U.V. Spectrometry, Theophylline |
| Device class | Class II |
| Regulation | 21 CFR 862.3880 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every LCY clearance
Top LCY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Syva Co. | 2 | 1978-04-12 |
| Gds Diagnostics | 1 | 1989-05-16 |
Most recent LCY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K891761 | Gds Diagnostics | GDS ENZYMATIC THEOPHYLLINE REAGENT | 1989-05-16 | 53 |
| K780442 | Syva Co. | THEOPHYLLINE ASSAY TO THE GEMSAEC | 1978-04-12 | 23 |
| K780441 | Syva Co. | THEOPHYLLINE ASSAY TO THE CENTRIFICHEM | 1978-04-12 | 23 |
Recalls for LCY devices
openFDA lists no recalls for product code LCY.
Frequently asked questions
What is FDA product code LCY?
LCY is the FDA product code for u.v. spectrometry, theophylline. It is a Class II device, regulated under 21 CFR 862.3880 and reviewed by the Clinical Toxicology panel.
What device class is LCY?
Class II, regulation 21 CFR 862.3880. Typical premarket route: 510(k).
How long does a 510(k) take for product code LCY?
Across 3 cleared submissions the average was 33 days from receipt to decision (median 23).
Which companies have the most LCY clearances?
Syva Co. (2); Gds Diagnostics (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LCY
- Run a recall and safety report across every LCY manufacturer
- Watch product code LCY for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Clinical Toxicology product codes · FDA product code lookup · 510(k) database search · 510(k) review times