Elecsys HBsAg II (100/200 tests)
FDA premarket approval P160019/S008 · decided 2018-11-06
Approval details
- PMA number
- P160019
- Supplement
- S008
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Elecsys HBsAg II (100/200 tests)
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Roche Diagnostics, Inc.
- Date received
- 2018-10-09
- Decision date
- 2018-11-06
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Indianapolis, IN
- Statement
- Addition of a secondary manufacturer/supplier of a component raw material.
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