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FDA 510(k)

PhAST instrument and PhAST Blood Culture Gram-negative Panel

K-Number: K253316 · 2026-06-26

ApplicantPhast Corp.
Decision Date2026-06-26
Product CodeSAN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PhAST instrument and PhAST Blood Culture Gram-negative Panel is the device name listed in this FDA 510(k) record. The listed applicant is Phast Corp.. It received FDA 510(k) clearance on 2026-06-26 under 510(k) number K253316. The device is classified under product code SAN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PhAST instrument and PhAST Blood Culture Gram-negative Panel?

PhAST instrument and PhAST Blood Culture Gram-negative Panel is a medical device that received FDA 510(k) clearance on 2026-06-26. The listed applicant is Phast Corp.. The 510(k) number is K253316.

When did PhAST instrument and PhAST Blood Culture Gram-negative Panel receive FDA 510(k) clearance?

PhAST instrument and PhAST Blood Culture Gram-negative Panel received FDA 510(k) clearance on 2026-06-26, under 510(k) number K253316.

Who is the listed applicant for PhAST instrument and PhAST Blood Culture Gram-negative Panel?

The FDA 510(k) record lists Phast Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PhAST instrument and PhAST Blood Culture Gram-negative Panel?

The FDA product code for PhAST instrument and PhAST Blood Culture Gram-negative Panel is SAN.

Related Devices (Code: SAN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260160VITEK REVEAL GN AST Assay and VITEK REVEAL AST SystembioMerieux, Inc.K253573ASTar BC G- KitQ-Linea ABK251875LifeScale Gram Negative Kit (LSGN) with the LifeScale AST systemAffinity Biosensors, LLCK241324LifeScale Gram Negative Kit (LSGN) with the LifeScale AST systemAffinity Biosensors, LLCK230675VITEK REVEAL GN AST Assay and VITEK REVEAL AST SystemSpecific Diagnostics, LLCK221688ASTar BC G- Kit and ASTar InstrumentQ-Linea AB

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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