R01830
by Remel, Inc.
R01830 is a Class II device made by Remel, Inc., cleared under FDA 510(k) K092819 on 15 Jul 2010 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00848838076824), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00848838076824 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK092819 | Date15 Jul 2010 | StatusActive |
Official records
- AccessGUDID record 00848838076824
- FDA 510(k) database K092819
Across registries
- FDA 510(k) K092819 decided 15 Jul 2010 Active
- FDA GUDID UDI-DI 00848838076824 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K092819
- Listed FDA GUDID 00848838076824
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Chromogenic VRE agar culture medium IVD
- Model / reference
- R01830
- Primary DI / UDI-DI
- 00848838076824
- 510(k) Number
- FDA product code
- JSO
- GMDN term
- Chromogenic VRE agar culture medium IVD
- Device class
- Class II
- Regulation number
- 866.1700
- GUDID distribution status
- In Commercial Distribution
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