Identifiers
- 510(k) Number
- K830061 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)
Thayer-Martin, Modified is a culture medium intended for the isolation of pathogenic Neisseria. It functions as a selective medium designed to support the growth of Neisseria gonorrhoeae from clinical specimens.
This device is classified as a Class II medical device under regulation number 866.2410. It received FDA 510(k) clearance under K830061.
Frequently asked questions
What is the primary clinical purpose of the Thayer-Martin, Modified medium?
This device is a selective culture medium specifically formulated to support the growth and isolation of pathogenic Neisseria, particularly Neisseria gonorrhoeae, from clinical specimens.
What is the regulatory status of this culture medium?
The Thayer-Martin, Modified medium is classified as a Class II medical device under regulation number 866.2410 and received FDA 510(k) clearance under submission number K830061.
Which medical specialty is this device associated with?
This device is categorized under the microbiology specialty, as it is designed for the laboratory cultivation and identification of specific pathogenic bacteria.
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, MODIFIED (K830061) — FDA 510(k) | Innolitics, Thayer-Martin Agar (Modified): Composition, Principle, Uses, and Colony ..., K830061 - THAYER-MARTIN | FDA 510 (k) | bioMerieux, Inc., THAYER-MARTIN, MODIFIED (K830061) — FDA 510(k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K830061 | Class II | Active |
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Manufacturer
- Manufacturer
- Biomerieux , Inc.
- FDA Applicant
- bioMerieux, Inc.
Sources (1)
- FDA 510(k) K830061 24 fields · synced Oct 6, 2026