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FDA 510(k) K253316 — PhAST instrument and PhAST Blood Culture Gram-negative Panel
FDA 510(k) index record K253316. Device: PhAST instrument and PhAST Blood Culture Gram-negative Panel. Applicant as listed: Phast Corp.. Decision date: 2026-06-26.
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"device_name": "PhAST instrument and PhAST Blood Culture Gram-negative Panel"
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2026-10-20
2026-10-20
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FDA 510(k) public index record K253316.
Device name: PhAST instrument and PhAST Blood Culture Gram-negative Panel. Applicant as listed: Phast Corp..
Decision date: 2026-06-26. Decision wording: Substantially Equivalent.
Product code: SAN. Regulation: 21 CFR 866.1650. Medical specialty: Microbiology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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