Aptima HBV Quant Assay
FDA premarket approval P170025/S001 · decided 2018-10-02
Approval details
- PMA number
- P170025
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Aptima HBV Quant Assay
- Generic name
- Hepatitis Viral B DNA Detection
- Applicant
- Hologic, Inc.
- Date received
- 2018-02-21
- Decision date
- 2018-10-02
- Days to decision
- 223 days
- Decision code
- APPR
- Product code
- MKT
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- Approval for the use of the Aptima HBV Quant Assay on the Panther System with the attachment of the Panther Fusion Module. The changes being approved include the addition of new hardware and updated software.
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510(k) clearances by this applicant
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