Improved Thayer Martin (Jembec)
by Granite Diagnostics, Inc. 510(k)
Active
510(k) K770875
Overview
The Improved Thayer Martin (Jembec) is a culture media device for the isolation of pathogenic Neisseria. It is classified as a microbiology device. The device is used in microbiology applications.
The device is supplied with a product code of JTY and is regulated under 866.2410. It has been cleared with a substantially equivalent decision and has an FDA 510K authorization with the number K770875. The device is intended for use in microbiology settings.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK770875 | Date3 Jun 1977 | 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- Withdrawn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