Identifiers
- 510(k) Number
- K864252 FDA 510(k)
- FDA Product Code
- JTY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.2410 FDA 510(k)
- Regulation Number
- 866.2410 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Thayer-Martin Jembec is a culture media device for the isolation of pathogenic Neisseria. It is a Class II medical device designed for microbiology laboratory use.
The device is supplied by Mds Laboratories, Inc. and is regulated under FDA 510(k) clearance K864252 with product code JTY. It was received on 1986-10-28 and deemed substantially equivalent on 1987-03-31 under regulation 866.2410.
Frequently asked questions
What is the Thayer-Martin Jembec used for?
The Thayer-Martin Jembec is a culture media device specifically designed for the isolation of pathogenic Neisseria in microbiology laboratory settings. It provides an optimal environment for growing and identifying these bacteria.
How is the Thayer-Martin Jembec supplied?
The Thayer-Martin Jembec is supplied by Mds Laboratories, Inc. It is a Class II medical device that comes ready for laboratory use, though specific packaging details aren't provided in the available information.
What is the regulatory status of the Thayer-Martin Jembec?
The Thayer-Martin Jembec is regulated under FDA 510(k) clearance K864252 with product code JTY. It was received on October 28, 1986, and deemed substantially equivalent on March 31, 1987, under regulation 866.2410.
Is the Thayer-Martin Jembec single-use or reusable?
The available information doesn't specify whether the Thayer-Martin Jembec is designed for single-use or multiple uses. As a culture media device, its usage would depend on laboratory protocols and standard microbiological practices.
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: THAYER-MARTIN JEMBEC (K864252) — FDA 510(k) | Innolitics, THAYER-MARTIN JEMBEC 510 (k) K864252 - FDA.report, Thayer-martin Jembec - Beudamed
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K864252 | Class II | Active |
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Manufacturer
- Manufacturer
- Mds Laboratories, Inc.
Sources (1)
- FDA 510(k) K864252 24 fields · synced Sep 28, 2026