FDA 510(k)

i-STAT Alinity System with i-STAT Sodium test

K-번호: K153357 · 2016-07-08

결정일2016-07-08

제품 코드JGS

자문 위원회CH [기업명]의 [제품명]은 미국 식품의약국(FDA)에서 510(k) 등록을 완료한 의료기기입니다. 이 제품은 [PMA] 및 [NCT] 등록을 완료하였으며, [PMID]로 확인할 수 있습니다. 더 자세한 정보는 다음 URL을 참조하세요: [URL].

결정대체적으로 동일

기기 요약

i-STAT Alinity System with i-STAT Sodium test is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Point of Care, Inc.. It received FDA 510(k) clearance on 2016-07-08 under 510(k) number K153357. The device is classified under product code JGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the i-STAT Alinity System with i-STAT Sodium test?

i-STAT Alinity System with i-STAT Sodium test is a medical device that received FDA 510(k) clearance on 2016-07-08. The listed applicant is Abbott Point of Care, Inc.. The 510(k) number is K153357.

When did i-STAT Alinity System with i-STAT Sodium test receive FDA 510(k) clearance?

i-STAT Alinity System with i-STAT Sodium test received FDA 510(k) clearance on 2016-07-08, under 510(k) number K153357.

Who is the listed applicant for i-STAT Alinity System with i-STAT Sodium test?

The FDA 510(k) record lists Abbott Point of Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for i-STAT Alinity System with i-STAT Sodium test?

The FDA product code for i-STAT Alinity System with i-STAT Sodium test is JGS.

Abbott Point of Care, Inc.를 신청인으로 등재한 기타 기록

K261039i-STAT Crea cartridge with the i-STAT 1 System K253051i-STAT hs-TnI cartridge with the i-STAT Alinity System K244014i-STAT CG4+ cartridge with the i-STAT 1 System K240984i-STAT hs-TnI cartridge with the i-STAT 1 System K230275i-STAT CG8+ cartridge with the i-STAT 1 System K230285i-STAT CG8+ cartridge with the i-STAT 1 System

19개 장치 모두 보기 →

공식 출처

FDA 데이터베이스에서 보기 →

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