면책 고지: 이 사이트는 FDA, ClinicalTrials.gov, PubMed, SEC EDGAR 등 공식 공개 데이터를 일반 참고용으로 집계하며, 의학적 조언, 진단, 치료 권고 또는 투자 조언이 아닙니다.

FDA 510(k)

신보우어 알파 디펜신 later flow 테스트 키트 (1 키트), 신보우어 알파 디펜신 later flow 테스트 키트 (5 테스트), 신보우어 알파 디펜신 later flow 테스트 키트 (10 테스트), 신보우어 알파 디펜신 flow 테스트 키트 (30 테스트), 신보우어 알파 디펜신 컨트롤 키트

K-번호: K212204 · 2021-08-11

결정일2021-08-11
제품 코드QGN
자문 위원회미 (Original text: MI)
결정대체적으로 동일

기기 요약

Synovasure Alpha Defensin Lateral Flow Test Kit (1 Kit), Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Flow Test Kit (30 Test), Synovasure Alpha Defensin Control Kit is the device name listed in this FDA 510(k) record. The listed applicant is Cd Diagnostics, Inc.. It received FDA 510(k) clearance on 2021-08-11 under 510(k) number K212204. The device is classified under product code QGN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Synovasure Alpha Defensin Lateral Flow Test Kit (1 Kit), Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Flow Test Kit (30 Test), Synovasure Alpha Defensin Control Kit?

Synovasure Alpha Defensin Lateral Flow Test Kit (1 Kit), Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Flow Test Kit (30 Test), Synovasure Alpha Defensin Control Kit is a medical device that received FDA 510(k) clearance on 2021-08-11. The listed applicant is Cd Diagnostics, Inc.. The 510(k) number is K212204.

When did Synovasure Alpha Defensin Lateral Flow Test Kit (1 Kit), Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Flow Test Kit (30 Test), Synovasure Alpha Defensin Control Kit receive FDA 510(k) clearance?

Synovasure Alpha Defensin Lateral Flow Test Kit (1 Kit), Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Flow Test Kit (30 Test), Synovasure Alpha Defensin Control Kit received FDA 510(k) clearance on 2021-08-11, under 510(k) number K212204.

Who is the listed applicant for Synovasure Alpha Defensin Lateral Flow Test Kit (1 Kit), Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Flow Test Kit (30 Test), Synovasure Alpha Defensin Control Kit?

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

What is the FDA product code for Synovasure Alpha Defensin Lateral Flow Test Kit (1 Kit), Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Flow Test Kit (30 Test), Synovasure Alpha Defensin Control Kit?

The FDA product code for Synovasure Alpha Defensin Lateral Flow Test Kit (1 Kit), Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Flow Test Kit (30 Test), Synovasure Alpha Defensin Control Kit is QGN.

관련 임상시험

관련 기록은 이름, 제품 코드 또는 기타 메타데이터를 사용하여 자동으로 매칭됩니다. 매칭은 검증된 임상, 과학, 기업 또는 규제 상의 관계를 입증하지 않으며, 연결된 공식 출처를 검토하시기 바랍니다.

공식 출처

FDA 데이터베이스에서 보기 →

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

↑