Lumipulse G TSH-III Immunoreaction Cartridges
FDA 510(k) clearance K171103 · decided 2017-07-28
Clearance details
- K-number
- K171103
- Device name
- Lumipulse G TSH-III Immunoreaction Cartridges
- Applicant
- Fujirebio Diagnostics,Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-04-13
- Decision date
- 2017-07-28
- Days to decision
- 106 days
- Clearance type
- Traditional
- Product code
- JLW
- Device class
- 2
- Regulation number
- 862.1690
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Malvern, PA, US
- Third-party review
- No
- Expedited review
- No
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| Elecsys TSH assay, cobas e 801 Immunoassay analyzer (K162606) | Roche Diagnostics | 2017-01-23 |
| Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control (K160541) | Sysmex America, Inc. | 2016-10-21 |
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Recalls involving this device
No recalls on record reference this clearance.