Aptima HCV Quant Dx Assay
FDA premarket approval P160023/S005 · decided 2018-08-07
Approval details
- PMA number
- P160023
- Supplement
- S005
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Aptima HCV Quant Dx Assay
- Generic name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
- Applicant
- Hologic, Inc.
- Date received
- 2018-07-09
- Decision date
- 2018-08-07
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MZP
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- Increase the batch size and modify the manufacturing process of a critical kit subcomponent.
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510(k) clearances by this applicant
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