Mod Thayer Martin Martin Lewis
by Micro Media Laboratories 510(k)
Active
510(k) K850841
Overview
The Mod Thayer Martin Martin Lewis is a culture medium for the isolation of pathogenic Neisseria. It is a type of microbiology device, specifically designed for use in microbiological applications. The medium contains peptone, starch, and lysed blood, which provide nutrients and enhance the growth of pathogenic Neisseria. Vancomycin and colistin methane sulphate are added to inhibit the growth of gram-positive and gram-negative bacteria.
The Mod Thayer Martin Martin Lewis is supplied as a culture medium and is used in microbiology settings. It is classified as a class 2 device and is regulated under the regulation number 866.2410. The device has been cleared under the FDA 510K premarket notification, with the clearance type being traditional. The device is associated with the product code JTY and has the registration numbers 1119779, 2022807, 1111096, 1924669, 3009547954, and 2951280.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK850841 | Date20 Mar 1985 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- JTY
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.2410
- Advisory Committee
- Microbiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Micro Media Laboratories
Questions
What is the Mod Thayer Martin Martin Lewis used for?
The Mod Thayer Martin Martin Lewis is used for the isolation of pathogenic Neisseria in microbiology settings, providing nutrients for their growth and inhibiting other bacteria.
How is the Mod Thayer Martin Martin Lewis supplied?
The Mod Thayer Martin Martin Lewis is supplied as a culture medium, containing peptone, starch, lysed blood, vancomycin, and colistin methane sulphate.
Is the Mod Thayer Martin Martin Lewis a single-use or reusable device?
The device data does not specify whether the Mod Thayer Martin Martin Lewis is single-use or reusable, but it is classified as a class 2 device.
What is the regulatory classification of the Mod Thayer Martin Martin Lewis?
The Mod Thayer Martin Martin Lewis is regulated under the regulation number 866.2410 and has been cleared under the FDA 510K premarket notification with a traditional clearance type.