FDA 510(k)

엔도토신 활성 검사 (EAA)

K-번호: K183176 · 2019-03-12

결정일2019-03-12

제품 코드NGS

자문 위원회미 (Original text: MI)

결정대체적으로 동일

기기 요약

Endotoxin Activity Assay (EAA) is the device name listed in this FDA 510(k) record. The listed applicant is Spectral Medical, Inc.. It received FDA 510(k) clearance on 2019-03-12 under 510(k) number K183176. The device is classified under product code NGS. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Endotoxin Activity Assay (EAA)?

Endotoxin Activity Assay (EAA) is a medical device that received FDA 510(k) clearance on 2019-03-12. The listed applicant is Spectral Medical, Inc.. The 510(k) number is K183176.

When did Endotoxin Activity Assay (EAA) receive FDA 510(k) clearance?

Endotoxin Activity Assay (EAA) received FDA 510(k) clearance on 2019-03-12, under 510(k) number K183176.

Who is the listed applicant for Endotoxin Activity Assay (EAA)?

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

What is the FDA product code for Endotoxin Activity Assay (EAA)?

The FDA product code for Endotoxin Activity Assay (EAA) is NGS.

Spectral Medical, Inc.를 신청인으로 등재한 기타 기록

K170790SAM CRRT 단위, SAM 캐세트 CRRT

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기기 요약

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관련 임상시험

Spectral Medical, Inc.를 신청인으로 등재한 기타 기록

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