FDA product code LBA: Procainamide Control Materials
LBA is the FDA product code for procainamide control materials. It is a Class I device, regulated under 21 CFR 862.3280 and reviewed by the Clinical Toxicology panel. FDA has cleared 1 510(k) submission under LBA. The average 510(k) review took 72 days (median 72).
Classification
| Field | Value |
|---|---|
| Device name | Procainamide Control Materials |
| Device class | Class I |
| Regulation | 21 CFR 862.3280 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LBA clearance
Top LBA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sonicaid, Inc. | 1 | 1983-10-27 |
Most recent LBA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K833227 | Sonicaid, Inc. | SONICAID MODEL D206E AIR EMBOLI-DETECT | 1983-10-27 | 72 |
Recalls for LBA devices
openFDA lists no recalls for product code LBA.
Frequently asked questions
What is FDA product code LBA?
LBA is the FDA product code for procainamide control materials. It is a Class I device, regulated under 21 CFR 862.3280 and reviewed by the Clinical Toxicology panel.
What device class is LBA?
Class I, regulation 21 CFR 862.3280. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LBA?
Across 1 cleared submissions the average was 72 days from receipt to decision (median 72).
Which companies have the most LBA clearances?
Sonicaid, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LBA
- Run a recall and safety report across every LBA manufacturer
- Watch product code LBA 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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