510(k) K242526
- Device
- Visby Medical Respiratory Health Test
- Applicant
- Visby Medical, Inc.
- 510(k) number
- K242526
- Product code
- QOF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-02-19
- Date received
- 2024-08-26
- Regulation
- 866.3981
- Classification name
- Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Dual Track
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Jennifer Albrecht
- Address
- 3010 N. First St. San Jose CA US 95134 95134
FDA Registration Numbers
- 3014654360
- 3009613136
- 2243471
- 1528450
- 3008632402
- 3004530258
- 3019837962
- 3009302820
- 2023365
- 2024800
- 3003795116
- 3010770794
- 3006028115
- 3014515702
- 3011057574
- 3021140368
- 3002777243
- 3014553740
- 3011240982
- 3011104381
- 3005248192
- 3035381641
- 3002773840
- 3004013603
- 3016838963
- 3009976420
- 3007420875
- 3006247421
- 1119779
- 3004141078
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
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| K242071 | Xpert Xpress CoV-2/Flu/RSV plus | Cepheid | 2025-01-10 |
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