Bartels B1029-581
Bartels B1029-581 is a Class I device made by Clark Laboratories, Inc., cleared under FDA 510(k) K834122 on 13 Feb 1984 and listed in FDA GUDID since 7 May 2017 (UDI-DI 05391516747363), 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 | Number05391516747363 | Date7 May 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK834122 | Date13 Feb 1984 | StatusActive |
Official records
- AccessGUDID record 05391516747363
- FDA 510(k) database K834122
Across registries
- FDA 510(k) K834122 decided 13 Feb 1984 Active
- FDA GUDID UDI-DI 05391516747363 listed 7 May 2017 Listed
Timeline
- Cleared FDA 510(k) K834122
- Listed FDA GUDID 05391516747363
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Bartels
- Generic name
- Culture medium antimicrobial supplement IVD
- Model / Ref / Catalog
- B1029-581
- Primary DI / UDI-DI
- 05391516747363
- 510(k) Number
- FDA product code
- KIT
- GMDN term
- Culture medium antimicrobial supplement IVD
- Device class
- Class I
- Regulation number
- 864.2220
- GUDID distribution status
- In Commercial Distribution
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