Class Class II

IntelliSep Test (K250912)

K250912 2025-11-19 Traditional
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Description

IntelliSep Test by Cytovale, Inc., an FDA 510(k) cleared microbiology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK250912
Clearance Date2025-11-19
Clearance TypeTraditional
Product CodeQUT
Regulation Number866.3215

Categories

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