ELECSYS HBEAG IMMUNOASSAY/ELECSYS PRECICONTROL HBEAG
FDA premarket approval P130015/S003 · decided 2015-07-28
Approval details
- PMA number
- P130015
- Supplement
- S003
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ELECSYS HBEAG IMMUNOASSAY/ELECSYS PRECICONTROL HBEAG
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Roche Diagnostics Operations, Inc.
- Date received
- 2015-06-29
- Decision date
- 2015-07-28
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Indianapolis, IN
- Statement
- ADDITION OF A WEAK POSITIVE CONTROL TO THE IN-PROCESS TESTING OF THE DEVICE.
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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 |