FDA 510(k)

Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR 키트

K-번호: K233453 · 2024-07-10

결정일2024-07-10

제품 코드QQX

자문 위원회미 (Original text: MI)

결정대체적으로 동일

기기 요약

Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit is the device name listed in this FDA 510(k) record. The listed applicant is Life Technologies Corporation. It received FDA 510(k) clearance on 2024-07-10 under 510(k) number K233453. The device is classified under product code QQX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit?

Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit is a medical device that received FDA 510(k) clearance on 2024-07-10. The listed applicant is Life Technologies Corporation. The 510(k) number is K233453.

When did Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit receive FDA 510(k) clearance?

Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit received FDA 510(k) clearance on 2024-07-10, under 510(k) number K233453.

Who is the listed applicant for Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit?

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

What is the FDA product code for Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit?

The FDA product code for Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit is QQX.

Life Technologies Corporation를 신청인으로 등재한 기타 기록

K241806Applied Biosystems™ TaqPath™ COVID-19,流感A,流感B, RSV 선택 패널 K191030Applied Biosystems™ 3500 Dx 유전 분석기 및 Applied Biosystems™ 3500xL Dx 유전 분석기 K170299이온 PGM Dx 시스템

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