FDA product code NAL: Test, Immunoassay, Biosensor, Hcg
NAL is the FDA product code for test, immunoassay, biosensor, hcg. It is a Class II device, regulated under 21 CFR 862.1155 and reviewed by the Clinical Chemistry panel. FDA has cleared 2 510(k) submissions under NAL. The average 510(k) review took 234 days (median 234).
Classification
| Field | Value |
|---|---|
| Device name | Test, Immunoassay, Biosensor, Hcg |
| Device class | Class II |
| Regulation | 21 CFR 862.1155 |
| 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 NAL clearance
Top NAL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Quantech , Ltd. | 2 | 2002-01-18 |
Most recent NAL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K012943 | Quantech , Ltd. | THE QUANTECH FASTRAQ AUTOMATED ANALYZER, AND THE QUANTECH PREPAQ TOTAL HCG TEST CARTRIDGE | 2002-01-18 | 140 |
| K990258 | Quantech , Ltd. | QUANTECH TOTAL B-HCG ASSAY | 1999-12-21 | 328 |
Recalls for NAL devices
openFDA lists no recalls for product code NAL.
Frequently asked questions
What is FDA product code NAL?
NAL is the FDA product code for test, immunoassay, biosensor, hcg. It is a Class II device, regulated under 21 CFR 862.1155 and reviewed by the Clinical Chemistry panel.
What device class is NAL?
Class II, regulation 21 CFR 862.1155. Typical premarket route: 510(k).
How long does a 510(k) take for product code NAL?
Across 2 cleared submissions the average was 234 days from receipt to decision (median 234).
Which companies have the most NAL clearances?
Quantech , Ltd. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code NAL
- Run a recall and safety report across every NAL manufacturer
- Watch product code NAL 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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