Aptima SARS-CoV-2 Assay— 510(k) K243396
Substantially EquivalentHologic, Inc.
FDA 510(k) clearance K243396 for Aptima SARS-CoV-2 Assay, Substantially Equivalent on 2025-02-13. Applicant: Hologic, Inc.. Device class: 2.
Clearance details
- Applicant
- Hologic, Inc.
- Product code
- Code QQX
- Device class
- Class 2
- Regulation
- 21 CFR 866.3981
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
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More clearances from Hologic, Inc.
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