Aviso: Este site agrega dados públicos oficiais da FDA, ClinicalTrials.gov, PubMed e SEC EDGAR apenas para referência geral. Não constitui aconselhamento médico, diagnóstico, recomendação de tratamento ou aconselhamento de investimento.

FDA 510(k)

Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream

Número K: K242135 · 2025-01-31

RequerenteNanjing Synthgene Medical Technology Co., Ltd.
Data da decisão2025-01-31
Código do produtoLCX
Comité consultivoCH
DecisãoSubstantially Equivalent

Resumo do dispositivo

Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream is the device name listed in this FDA 510(k) record. The listed applicant is Nanjing Synthgene Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-01-31 under 510(k) number K242135. The device is classified under product code LCX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream?

Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream is a medical device that received FDA 510(k) clearance on 2025-01-31. The listed applicant is Nanjing Synthgene Medical Technology Co., Ltd.. The 510(k) number is K242135.

When did Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream receive FDA 510(k) clearance?

Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream received FDA 510(k) clearance on 2025-01-31, under 510(k) number K242135.

Who is the listed applicant for Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream?

The FDA 510(k) record lists Nanjing Synthgene Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream?

The FDA product code for Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream is LCX.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositivos Relacionados (Código: LCX)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

K251040MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy TestGuangzhou Decheng Biotechnology Co., Ltd.K251053Shinetell PlusTM Digital Early Pregnancy TestHangzhou AllTest Biotech Co., Ltd.K250117FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test CassetteAssure Tech., LLCK243573FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test MidstreamAssure Tech., LLCK241394iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test StripAndon Health Co, Ltd.K240242HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold)Anhui Deepblue Medical Technology Co., Ltd.

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.

↑