FDA product code MPG: Urinary Carbohydrate Analysis Kit
MPG is the FDA product code for urinary carbohydrate analysis kit. It is a Class I device, regulated under 21 CFR 862.1505 and reviewed by the Clinical Chemistry panel. FDA has cleared 1 510(k) submission under MPG. The average 510(k) review took 359 days (median 359).
Classification
| Field | Value |
|---|---|
| Device name | Urinary Carbohydrate Analysis Kit |
| Device class | Class I |
| Regulation | 21 CFR 862.1505 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Top MPG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Pharmaquest Corp. | 1 | 1995-11-03 |
Most recent MPG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K945519 | Pharmaquest Corp. | FACE (FLUOROPHORE-ASSISTED-CARBOHYDRATE-ELECTROPHORESIS) URINARY CARBOHYDRATE ANALYSIS SYSTEM | 1995-11-03 | 359 |
Recalls for MPG devices
openFDA lists no recalls for product code MPG.
Frequently asked questions
What is FDA product code MPG?
MPG is the FDA product code for urinary carbohydrate analysis kit. It is a Class I device, regulated under 21 CFR 862.1505 and reviewed by the Clinical Chemistry panel.
What device class is MPG?
Class I, regulation 21 CFR 862.1505. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code MPG?
Across 1 cleared submissions the average was 359 days from receipt to decision (median 359).
Which companies have the most MPG clearances?
Pharmaquest Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MPG
- Run a recall and safety report across every MPG manufacturer
- Watch product code MPG 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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