FDA 510(k)

Alinity m SARS-CoV-2 AMP 키트 (09N78-096); Alinity m SARS-CoV-2 CTRL 키트 (09N78-086)

K-번호: K241580 · 2024-12-06

결정일2024-12-06

제품 코드QQX

자문 위원회미 (Original text: MI)

결정Substantially Equivalent

기기 요약

Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086) is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Molecular. It received FDA 510(k) clearance on 2024-12-06 under 510(k) number K241580. 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 Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)?

Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086) is a medical device that received FDA 510(k) clearance on 2024-12-06. The listed applicant is Abbott Molecular. The 510(k) number is K241580.

When did Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086) receive FDA 510(k) clearance?

Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086) received FDA 510(k) clearance on 2024-12-06, under 510(k) number K241580.

Who is the listed applicant for Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)?

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

What is the FDA product code for Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)?

The FDA product code for Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086) is QQX.

Abbott Molecular를 신청인으로 등재한 기타 기록

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