Aptima HCV Quant Dx Assay— 510(k) K233352
Substantially EquivalentHologic, Inc.
FDA 510(k) clearance K233352 for Aptima HCV Quant Dx Assay, Substantially Equivalent on 2024-07-24. Applicant: Hologic, Inc.. Device class: 2.
Clearance details
- Applicant
- Hologic, Inc.
- Product code
- Code MZP
- Device class
- Class 2
- Regulation
- 21 CFR 866.3170
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Recent devices under product code MZP
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