FDA 510(k)

심픽사 HSV 1 & 2 직접 검사, 심픽사 HSV 1 & 2 양성 조절 팩

K-번호: K173798 · 2018-03-14

결정일2018-03-14

제품 코드PGI

자문 위원회미 (Original text: MI)

결정대체적으로 동일

기기 요약

Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack is the device name listed in this FDA 510(k) record. The listed applicant is Diasorin Molecular, LLC. It received FDA 510(k) clearance on 2018-03-14 under 510(k) number K173798. The device is classified under product code PGI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack?

Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack is a medical device that received FDA 510(k) clearance on 2018-03-14. The listed applicant is Diasorin Molecular, LLC. The 510(k) number is K173798.

When did Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack receive FDA 510(k) clearance?

Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack received FDA 510(k) clearance on 2018-03-14, under 510(k) number K173798.

Who is the listed applicant for Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack?

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

What is the FDA product code for Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack?

The FDA product code for Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack is PGI.

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