Elecsys HBsAg II
FDA premarket approval P160019/S017 · decided 2024-08-29
Approval details
- PMA number
- P160019
- Supplement
- S017
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Elecsys HBsAg II
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Roche Diagnostics, Inc.
- Date received
- 2024-08-02
- Decision date
- 2024-08-29
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Indianapolis, IN
- Statement
- two additional fill lines
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.