FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Panther Fusion AdV/hMPV/RV Assay
K Number: K231017
·
Decision May 5, 2023
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
77
Applicant Total
32
Review Days
25
Basic Information
- Device Name
- Panther Fusion AdV/hMPV/RV Assay
- K Number
- K231017
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 866.3980
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hologic, Inc.
- Date Received
- April 10, 2023
- Decision Date
- May 5, 2023
- Product Code
- OCC
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OCC | Respiratory Virus Panel Nucleic Acid Assay System | FDA class 2 | Microbiology |
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Other Clearances by Hologic, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| K243345 | Aptima BV Assay; Aptima CV/TV Assay | Nov 25, 2024 | Substantially Equivalent |
| K242465 | Panther Fusion SARS-CoV-2/Flu A/B/RSV assay | Nov 15, 2024 | Substantially Equivalent |
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| K233352 | Aptima HCV Quant Dx Assay | Jul 24, 2024 | Substantially Equivalent |
| K241240 | Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay | Jul 18, 2024 | Substantially Equivalent |
| K231329 | Aptima Neisseria gonorrhoeae Assay | Jan 26, 2024 | Substantially Equivalent |
| K230451 | Aptima® Chlamydia trachomatis Assay | Nov 16, 2023 | Substantially Equivalent |
| K231316 | Aptima Trichomonas vaginalis Assay | Nov 6, 2023 | Substantially Equivalent |