ELECSYS HBEAG AND PRECICONTROL HBEAG
FDA premarket approval P130015/S009 · decided 2017-01-13
Approval details
- PMA number
- P130015
- Supplement
- S009
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- ELECSYS HBEAG AND PRECICONTROL HBEAG
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Roche Diagnostics Operations, Inc.
- Date received
- 2016-12-20
- Decision date
- 2017-01-13
- Days to decision
- 24 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Indianapolis, IN
- Statement
- Approval for the change of proprietary names of Elecsys HBeAg Immunoassay and Elecsys PreciControl HBeAg to Elecsys HBeAg and PreciControl HBeAg.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |