FDA 510(k)

PhAST instrument and PhAST Blood Culture Gram-negative Panel

Número K: K253316 · 2026-06-26

Data da decisão2026-06-26

Código do produtoSAN

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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