FDA product code PYP: Low-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test
PYP is the FDA product code for low-density lipoprotein (ldl) cholesterol sub-fraction test. It is a Class I device, regulated under 21 CFR 862.1475 and reviewed by the Clinical Chemistry panel. FDA has cleared 1 510(k) submission under PYP. The average 510(k) review took 427 days (median 427).
Definition
For the quantitative determination of low-density lipoprotein (LDL) cholesterol sub-fractions.
Classification
| Field | Value |
|---|---|
| Device name | Low-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test |
| Device class | Class I |
| Regulation | 21 CFR 862.1475 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for PYP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 427 |
Compare with all 510(k) review times · Search every PYP clearance
Top PYP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Denka Seiken Co., Ltd. | 1 | 2017-08-18 |
Most recent PYP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K161679 | Denka Seiken Co., Ltd. | s LDL-EX SEIKEN | 2017-08-18 | 427 |
Recalls for PYP devices
openFDA lists no recalls for product code PYP.
Frequently asked questions
What is FDA product code PYP?
PYP is the FDA product code for low-density lipoprotein (ldl) cholesterol sub-fraction test. It is a Class I device, regulated under 21 CFR 862.1475 and reviewed by the Clinical Chemistry panel.
What device class is PYP?
Class I, regulation 21 CFR 862.1475. Typical premarket route: 510(k).
How long does a 510(k) take for product code PYP?
Across 1 cleared submissions the average was 427 days from receipt to decision (median 427).
Which companies have the most PYP clearances?
Denka Seiken Co., Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PYP
- Run a recall and safety report across every PYP manufacturer
- Watch product code PYP 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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