ELECSYS® HBEAG IMMUNOASSAY AND ELECSYS® PRECICONTROL HBEAG
FDA premarket approval P130015/S006 · decided 2016-03-16
Approval details
- PMA number
- P130015
- Supplement
- S006
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ELECSYS® HBEAG IMMUNOASSAY AND ELECSYS® PRECICONTROL HBEAG
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Roche Diagnostics Operations, Inc.
- Date received
- 2016-02-16
- Decision date
- 2016-03-16
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Indianapolis, IN
- Statement
- Relocation of manufacturing activities for the purification and production of antibodies and proteins and for the lyophilization of raw materials and addition of new lyophilization equipment.
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 |