FDA 510(k)

EliA anti-TG 면역측정, EliA anti-TPO 면역측정, EliA 쥐어질이 긍정적 제어 250, EliA 쥐어질이 긍정적 제어 2500/5000

K-번호: K151799 · 2016-03-25

결정일2016-03-25

제품 코드JZO

자문 위원회IM

결정대체적으로 동일

기기 요약

EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000 is the device name listed in this FDA 510(k) record. The listed applicant is Phadia AB. It received FDA 510(k) clearance on 2016-03-25 under 510(k) number K151799. The device is classified under product code JZO. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000?

EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000 is a medical device that received FDA 510(k) clearance on 2016-03-25. The listed applicant is Phadia AB. The 510(k) number is K151799.

When did EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000 receive FDA 510(k) clearance?

EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000 received FDA 510(k) clearance on 2016-03-25, under 510(k) number K151799.

Who is the listed applicant for EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000?

The FDA 510(k) record lists Phadia AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000?

The FDA product code for EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000 is JZO.

Phadia AB를 신청인으로 등재한 기타 기록

K253367EliA CTD 13 스크린 K212181ImmunoCAP 알러진 f433, 알러진 구성 요소 rTri a 14 LTP,小麦, ImmunoCAP 알러진 f416, 알러진 구성 요소 rTri a 19 오메가-5 Gliadin,小麦, ImmunoCAP 알러진 f449, 알러진 구성 요소 rSes i 1 씨앗 K210902EliA Ro52, EliA Ro60 K202540엘리아 라이브-피 K202541엘리아 RNA Pol III K202067엘리아 스름-디-에스

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