Elecsys HBeAg Test System
FDA premarket approval P130015/S017 · decided 2023-04-18
Approval details
- PMA number
- P130015
- Supplement
- S017
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Elecsys HBeAg Test System
- Applicant
- Roche Diagnostics Operations, Inc.
- Date received
- 2022-09-30
- Decision date
- 2023-04-18
- Days to decision
- 200 days
- Decision code
- APPR
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Indianapolis, IN
- Statement
- Approval for the migration of the Elecsys HBeAg Immunoassay and Elecsys PreciControl HBeAg to the cobas e 402 immunoassay analyzer
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM (K131366) | Roche Diagnostics Operations, Inc. | 2013-10-11 |
| ACCU-CHEK AVIVA PLUS TEST STRIP (K131029) | Roche Diagnostics Operations, Inc. | 2013-08-09 |