Identifiers
- 510(k) Number
- K020532 FDA 510(k)
- FDA Product Code
- LCP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 864.7470 FDA 510(k)
- Regulation Number
- 864.7470 FDA 510(k)
- Advisory Committee
- Hematology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Polymedco HbA1c Test is an assay for glycosylated hemoglobin, classified under the medical specialty of Hematology. It is a device used to measure the level of glycosylated hemoglobin in the blood.
The device is supplied with a product code of LCP and is regulated under the regulation number 864.7470. It has been cleared by the FDA under the traditional clearance type with the K number K020532. The device is intended for use in a laboratory setting and is not described as single-use or reusable in the provided data.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K020532 FDA 510(k) - POLYMEDCO HBA1C TEST | Polymedco, Inc., PDF K020532 POLYMEDCO HBA1C TEST - 510kdatabase.net, Polymedco HBA500X - HbA1c Aggluntinator Reagent Test Kit 3x115 Count Ea, PDF OC-LighLightt Ò Manual iFOBT Ki
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K020532 | Class II | Active |
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Manufacturer
- Manufacturer
- Polymedco, Inc.
Sources (1)
- FDA 510(k) K020532 24 fields · synced Sep 22, 2026