Medical Device Manufacturer · US , San Francisco , CA

Cytovale, Inc. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2022
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Cytovale, Inc. Microbiology ✕
3 devices
1-3 of 3
Cleared Nov 19, 2025
IntelliSep Test
K250912 · QUT
Microbiology · 237d
Cleared Mar 21, 2025
IntelliSep Test (CV-ICG-048)
K250513 · QUT
Microbiology · 28d
Cleared CT Dec 20, 2022
IntelliSep test
K220991 · QUT
Microbiology · 260d
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