FDA product code LPW: System, Test, Oxalate
LPW is the FDA product code for system, test, oxalate. It is a Class I device, regulated under 21 CFR 862.1542 and reviewed by the Clinical Chemistry panel. FDA has cleared 1 510(k) submission under LPW. The average 510(k) review took 69 days (median 69).
Classification
| Field | Value |
|---|---|
| Device name | System, Test, Oxalate |
| Device class | Class I |
| Regulation | 21 CFR 862.1542 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LPW clearance
Top LPW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sigma Chemical Co. | 1 | 1988-10-25 |
Most recent LPW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K883525 | Sigma Chemical Co. | OXALATE REAGENT | 1988-10-25 | 69 |
Recalls for LPW devices
openFDA lists no recalls for product code LPW.
Frequently asked questions
What is FDA product code LPW?
LPW is the FDA product code for system, test, oxalate. It is a Class I device, regulated under 21 CFR 862.1542 and reviewed by the Clinical Chemistry panel.
What device class is LPW?
Class I, regulation 21 CFR 862.1542. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LPW?
Across 1 cleared submissions the average was 69 days from receipt to decision (median 69).
Which companies have the most LPW clearances?
Sigma Chemical Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LPW
- Run a recall and safety report across every LPW manufacturer
- Watch product code LPW 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 Chemistry product codes · FDA product code lookup · 510(k) database search · 510(k) review times