FDA product code DLT: Hemagglutination, Opiates
DLT is the FDA product code for hemagglutination, opiates. It is a Class II device, regulated under 21 CFR 862.3650 and reviewed by the Clinical Toxicology panel. FDA has cleared 1 510(k) submission under DLT. The average 510(k) review took 109 days (median 109).
Classification
| Field | Value |
|---|---|
| Device name | Hemagglutination, Opiates |
| Device class | Class II |
| Regulation | 21 CFR 862.3650 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Top DLT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Syva Co. | 1 | 1979-06-15 |
Most recent DLT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K790400 | Syva Co. | URINE NEGATIVE CALIBRATOR | 1979-06-15 | 109 |
Recalls for DLT devices
openFDA lists no recalls for product code DLT.
Frequently asked questions
What is FDA product code DLT?
DLT is the FDA product code for hemagglutination, opiates. It is a Class II device, regulated under 21 CFR 862.3650 and reviewed by the Clinical Toxicology panel.
What device class is DLT?
Class II, regulation 21 CFR 862.3650. Typical premarket route: 510(k).
How long does a 510(k) take for product code DLT?
Across 1 cleared submissions the average was 109 days from receipt to decision (median 109).
Which companies have the most DLT clearances?
Syva Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DLT
- Run a recall and safety report across every DLT manufacturer
- Watch product code DLT 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.
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