Identifiers
- 510(k) Number
- K912020 FDA 510(k)
- FDA Product Code
- LRM FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.5100 FDA 510(k)
- Regulation Number
- 866.5100 FDA 510(k)
- Advisory Committee
- Immunology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Anti-DNA Microassay is an immunology device used for detecting anti-DNA antibodies in patient samples. It is classified as an enzyme-labeled antigen control for laboratory testing purposes.
This device is supplied as a microassay format and is intended for single-use in clinical laboratory settings. It is a Class II device cleared by the FDA under product code LRM with FDA 510(k) clearance number K912020.
Frequently asked questions
What is the Anti-DNA Microassay used for?
The Anti-DNA Microassay is an immunology device used for detecting anti-DNA antibodies in patient samples. It is designed for laboratory testing purposes and comes in a microassay format.
How is the Anti-DNA Microassay supplied?
The device is supplied as a microassay format and is intended for single-use in clinical laboratory settings. Each unit should be used only once according to the manufacturer's instructions.
What is the regulatory status of the Anti-DNA Microassay?
The Anti-DNA Microassay is a Class II device cleared by the FDA under product code LRM with FDA 510(k) clearance number K912020. It was received by the FDA on May 7, 1991, and cleared on September 23, 1991.
What are the specifications of the Anti-DNA Microassay?
The Anti-DNA Microassay is classified as an enzyme-labeled antigen control for laboratory testing purposes. It is manufactured by Diamedix Corp. in Miami, FL, and is part of the immunology product category.
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: ANTI-DNA MICROASSAY (K863717) — FDA 510 (k) | Innolitics, ANTI-DNA MICROASSAY 510 (k) K863717 - FDA.report, K872560 FDA 510 (k) - ANTI-DNP MICROASSAY | Diamedix Corp., Diamedix Corp. · DeviceClearance, PDF K912020 - Anti-dna Microassay
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K912020 | Class II | Active |
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Manufacturer
- Manufacturer
- Diamedix Corp.
Sources (1)
- FDA 510(k) K912020 24 fields · synced Sep 27, 2026