POX · Class II · 21 CFR 862.3645

FDA Product Code POX: Enzyme Immunoassay, Oxcarbazepine Metabolite

An Oxcarbazepine Metabolite Assay Is An Enzyme Immunoassay Intended For The Quantitative Determination Of Oxcarbazepine Metabolite In Human Serum. The Measurements Obtained Are Used In Monitoring Levels Of Oxcarbazepine Metabolite To Help Ensure Appropriate Therapy.

1
Total
1
Cleared
237d
Avg days
2016
Since

FDA 510(k) Cleared Enzyme Immunoassay, Oxcarbazepine Metabolite Devices (Product Code POX)

1 devices
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No devices found for this product code.

About Product Code POX - Regulatory Context