FDA product code NAQ: Lipoprotein, High Density, Hdl, Over The Counter
NAQ is the FDA product code for lipoprotein, high density, hdl, over the counter. It is a Class I device, regulated under 21 CFR 862.1175 and reviewed by the Clinical Chemistry panel. FDA has cleared 2 510(k) submissions under NAQ. The average 510(k) review took 68 days (median 68). FDA has posted 1 recall for NAQ devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Lipoprotein, High Density, Hdl, Over The Counter |
| Device class | Class I |
| Regulation | 21 CFR 862.1175 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every NAQ clearance
Top NAQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Polymer Technology Systems, Inc. | 2 | 2006-04-05 |
Most recent NAQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K060617 | Polymer Technology Systems, Inc. | PTS PANELS HDL CHOLESTEROL TEST STRIPS | 2006-04-05 | 28 |
| K993377 | Polymer Technology Systems, Inc. | MTM BIOSCANNER HDL TEST STRIPS, OVER THE COUNTER (OTC) | 2000-01-13 | 107 |
Recalls for NAQ devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-11-03.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code NAQ?
NAQ is the FDA product code for lipoprotein, high density, hdl, over the counter. It is a Class I device, regulated under 21 CFR 862.1175 and reviewed by the Clinical Chemistry panel.
What device class is NAQ?
Class I, regulation 21 CFR 862.1175. Typical premarket route: 510(k).
How long does a 510(k) take for product code NAQ?
Across 2 cleared submissions the average was 68 days from receipt to decision (median 68).
Which companies have the most NAQ clearances?
Polymer Technology Systems, Inc. (2).
Have NAQ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2025-11-03.
Next steps
- Run an FDA pathway report with predicate devices for product code NAQ
- Run a recall and safety report across every NAQ manufacturer
- Watch product code NAQ 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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