Intray Gc
510(k) K993033
Intray Gc is a Class II device made by Biomed Diagnostics, Inc., cleared under FDA 510(k) K993033 on 16 Dec 1999, active as of 10 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK993033 | Date16 Dec 1999 | StatusActive |
Official records
- FDA 510(k) database K993033
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
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
Devices cleared under K993033
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| InTray™ GC 1080 | 10-8000 / 1080 | B08810800 | — | On the market |
Similar devices
Other devices filed under FDA product code JTY (Culture Media, For Isolation Of Pathogenic Neisseria).
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- LAB-TEK JEMBEC G.C. CULTURE SYSTEM by Miles Laboratories, Inc.
- MARTIN-LEWIS AGAR MEDIUM by Gibco Laboratories Life Technologies, Inc.
- MARTIN-LEWIS AGAR by Isle Media and Sterile Products, Inc.
- GC Culture Medium by Biolog, Inc.
- THAYER MARTIN AGAR by Mds Laboratories, Inc.
- Proteose No. 3 Agar by Acumedia Manufacturers, Inc.
- Thayer-Martin, Modified by BIOMERIEUX, INC.