FDA product code LAA: High Pressure Liquid Chromatography, Benzodiazepine
LAA is the FDA product code for high pressure liquid chromatography, benzodiazepine. It is a Class II device, regulated under 21 CFR 862.3170 and reviewed by the Clinical Toxicology panel. FDA has cleared 1 510(k) submission under LAA. The average 510(k) review took 82 days (median 82).
Classification
| Field | Value |
|---|---|
| Device name | High Pressure Liquid Chromatography, Benzodiazepine |
| Device class | Class II |
| Regulation | 21 CFR 862.3170 |
| 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 LAA clearance
Top LAA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bio-Rad | 1 | 1996-01-30 |
Most recent LAA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K955116 | Bio-Rad | BENZODIAZEPINES BY REMEDI HS | 1996-01-30 | 82 |
Recalls for LAA devices
openFDA lists no recalls for product code LAA.
Frequently asked questions
What is FDA product code LAA?
LAA is the FDA product code for high pressure liquid chromatography, benzodiazepine. It is a Class II device, regulated under 21 CFR 862.3170 and reviewed by the Clinical Toxicology panel.
What device class is LAA?
Class II, regulation 21 CFR 862.3170. Typical premarket route: 510(k).
How long does a 510(k) take for product code LAA?
Across 1 cleared submissions the average was 82 days from receipt to decision (median 82).
Which companies have the most LAA clearances?
Bio-Rad (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LAA
- Run a recall and safety report across every LAA manufacturer
- Watch product code LAA 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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