Elecsys Anti-HAV II
FDA 510(k) clearance K190428 · decided 2019-08-13
Clearance details
- K-number
- K190428
- Device name
- Elecsys Anti-HAV II
- Applicant
- Roche Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2019-02-22
- Decision date
- 2019-08-13
- Days to decision
- 172 days
- Clearance type
- Traditional
- Product code
- LOL
- Device class
- 2
- Regulation number
- 866.3310
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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| LIAISON Anti-HAV Assay (K193532) | DiaSorin, Inc. | 2020-03-02 |
| ADVIA Centaur HAV IgM Assay (K161964) | Siemens Healthcare Diagnostics, Inc. | 2016-10-13 |
| LIAISON HAV IgM, LIAISON Control HAV IgM (K160650) | DiaSorin, Inc. | 2016-08-25 |
| ADVIA Centaur HAV total assay (K142758) | Siemens Healthcare Diagnostics, Inc. | 2014-12-05 |
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S010) | Roche Diagnostics | 2025-05-22 |
| Elecsys Anti-HBe (P190005/S007) | Roche Diagnostics | 2025-05-22 |
| Elecsys Anti-HBe (P190005/S006) | Roche Diagnostics | 2024-10-03 |
| Elecsys Anti-HBs / Elecsys HBs II (P190034/S009) | Roche Diagnostics | 2024-10-03 |
| Elecsys Anti-HBs II (P190034/S008) | Roche Diagnostics | 2024-08-29 |
| Elecsys Anti-HBe (P190005/S005) | Roche Diagnostics | 2024-08-29 |
| Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S007) | Roche Diagnostics | 2024-07-23 |
| Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S005) | Roche Diagnostics | 2024-05-01 |