FDA 510(k)

QUANTA 플래시 dsDNA, QUANTA 플래시 dsDNA 캘리브레이터 및 QUANTA 플래시 dsDNA 컨트롤

K-번호: K152013 · 2016-04-11

결정일2016-04-11

제품 코드LSW

자문 위원회IM

결정대체적으로 동일

기기 요약

QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls is the device name listed in this FDA 510(k) record. The listed applicant is Inova Diagnostics, Inc.. It received FDA 510(k) clearance on 2016-04-11 under 510(k) number K152013. The device is classified under product code LSW. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls?

QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls is a medical device that received FDA 510(k) clearance on 2016-04-11. The listed applicant is Inova Diagnostics, Inc.. The 510(k) number is K152013.

When did QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls receive FDA 510(k) clearance?

QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls received FDA 510(k) clearance on 2016-04-11, under 510(k) number K152013.

Who is the listed applicant for QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls?

The FDA 510(k) record lists Inova Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls?

The FDA product code for QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls is LSW.

Inova Diagnostics, Inc.를 신청인으로 등재한 기타 기록

K243979Aptiva APS IgA Reagent K223093Aptiva APS IgG Reagent; Aptiva APS IgM Reagent K213403Aptiva CTD Essential Reagent K200230Aptiva 셀리악병 IgG 재료 K193604Aptiva 셀리악병 IgA 재료 K192916NOVA Lite DAPI dsDNA Crithidia luciliae 키트

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