FDA 510(k)

ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG 치료기, ARCHITECT HSV-1 IgG 제어기

K-번호: K213987 · 2023-09-20

결정일2023-09-20

제품 코드MXJ

자문 위원회미 (Original text: MI)

결정대체적으로 동일

기기 요약

ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls is the device name listed in this FDA 510(k) record. The listed applicant is Biokit, S.A.. It received FDA 510(k) clearance on 2023-09-20 under 510(k) number K213987. The device is classified under product code MXJ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls?

ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls is a medical device that received FDA 510(k) clearance on 2023-09-20. The listed applicant is Biokit, S.A.. The 510(k) number is K213987.

When did ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls receive FDA 510(k) clearance?

ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls received FDA 510(k) clearance on 2023-09-20, under 510(k) number K213987.

Who is the listed applicant for ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls?

The FDA 510(k) record lists Biokit, S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls?

The FDA product code for ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls is MXJ.

Biokit, S.A.를 신청인으로 등재한 기타 기록

K243575ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG 캘리브레이터, ARCHITECT HSV-2 IgG 컨트롤 K233606ADVIA Centaur EBV-VCA IgM K233605ADVIA Centaur EBV-EBNA IgG K214068쿼엔티아 IgE K181334ADVIA Centaur 히르스푸스 2 IgG K181333ADVIA Centaur 히르스푸스 1 IgG

8개 장치 모두 보기 →

공식 출처

FDA 데이터베이스에서 보기 →

FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.