Access Syphilis
510(k) K241427
Access Syphilis is a Class II device made by Beckman Coulter, Inc., cleared under FDA 510(k) K241427 on 6 Sep 2024, active as of 22 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 | NumberK241427 | Date6 Sep 2024 | StatusActive |
Official records
- FDA 510(k) database K241427
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LIP
- Device class
- Class II
- Regulation
- 21 CFR Part 866.3830
- Advisory committee
- Microbiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K241427
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 | |||
|---|---|---|---|---|
| Access Syphilis Reagent C80411 | C80411 / C80411 | 15099590763626 | — | On the market |
Similar devices
Other devices filed under FDA product code LIP (Enzyme Linked Immunoabsorption Assay, Treponema Pallidum).
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- TREPCHEK TREPONEMAL ANTIBODY EIA by Phoenix Biotech Corp.
- Lumipulse G TP-N Immunoreaction Cartridge Set by Fujirebio Diagnostics, Inc.
- IMMULITE® Systems SYP CONTROL Syphilis Screen 10469593 LSYCM by SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- ENZY-WELL SYPHILIS IGG, MODEL 91106 by DIESSE DIAGNOSTICA SENESE S.P.A
- TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS; QUALITY CONTROL MATERIALS by Siemens Healthcare Diagnostics
- CORDIA S4 -TREPONEMA PALLIDUM by Cordis US Corp.