Lyme-ID IgG Test; Bio-ID800
K-번호: K252627 · 2025-11-14
광고
기기 요약
Lyme-ID IgG Test; Bio-ID800 is the device name listed in this FDA 510(k) record. The listed applicant is Inanovate, Inc.. It received FDA 510(k) clearance on 2025-11-14 under 510(k) number K252627. The device is classified under product code LSR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
자주 묻는 질문
What is the Lyme-ID IgG Test; Bio-ID800?
Lyme-ID IgG Test; Bio-ID800 is a medical device that received FDA 510(k) clearance on 2025-11-14. The listed applicant is Inanovate, Inc.. The 510(k) number is K252627.
When did Lyme-ID IgG Test; Bio-ID800 receive FDA 510(k) clearance?
Lyme-ID IgG Test; Bio-ID800 received FDA 510(k) clearance on 2025-11-14, under 510(k) number K252627.
Who is the listed applicant for Lyme-ID IgG Test; Bio-ID800?
The FDA 510(k) record lists Inanovate, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Lyme-ID IgG Test; Bio-ID800?
The FDA product code for Lyme-ID IgG Test; Bio-ID800 is LSR.
관련 기기 (코드: LSR)
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.
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공식 출처
FDA 데이터베이스에서 보기 →FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.
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