FDA product code LTB: Cyclosporine Radioimmunoassay
LTB is the FDA product code for cyclosporine radioimmunoassay. It is a Class II device, regulated under 21 CFR 862.1235 and reviewed by the Clinical Toxicology panel. FDA has cleared 1 510(k) submission under LTB. The average 510(k) review took 15 days (median 15). 1 PMA application cites this product code.
Classification
| Field | Value |
|---|---|
| Device name | Cyclosporine Radioimmunoassay |
| Device class | Class II |
| Regulation | 21 CFR 862.1235 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every LTB clearance
Top LTB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Techhnilab Instruments, Inc. | 1 | 1981-12-31 |
Most recent LTB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K813523 | Techhnilab Instruments, Inc. | ELECTRIC SELF STERILIZATION INOCUL. LOOP | 1981-12-31 | 15 |
Recalls for LTB devices
openFDA lists no recalls for product code LTB.
Frequently asked questions
What is FDA product code LTB?
LTB is the FDA product code for cyclosporine radioimmunoassay. It is a Class II device, regulated under 21 CFR 862.1235 and reviewed by the Clinical Toxicology panel.
What device class is LTB?
Class II, regulation 21 CFR 862.1235. Typical premarket route: 510(k).
How long does a 510(k) take for product code LTB?
Across 1 cleared submissions the average was 15 days from receipt to decision (median 15).
Which companies have the most LTB clearances?
Techhnilab Instruments, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LTB
- Run a recall and safety report across every LTB manufacturer
- Watch product code LTB 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