FDA 510(k)

One Step Pregnancy Test

Número K: K210341 · 2022-03-10

RequerenteSpd Swiss Precision Diagnostics GmbH

Data da decisão2022-03-10

Código do produtoLCX

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

One Step Pregnancy Test is the device name listed in this FDA 510(k) record. The listed applicant is Spd Swiss Precision Diagnostics GmbH. It received FDA 510(k) clearance on 2022-03-10 under 510(k) number K210341. 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 One Step Pregnancy Test?

One Step Pregnancy Test is a medical device that received FDA 510(k) clearance on 2022-03-10. The listed applicant is Spd Swiss Precision Diagnostics GmbH. The 510(k) number is K210341.

When did One Step Pregnancy Test receive FDA 510(k) clearance?

One Step Pregnancy Test received FDA 510(k) clearance on 2022-03-10, under 510(k) number K210341.

Who is the listed applicant for One Step Pregnancy Test?

The FDA 510(k) record lists Spd Swiss Precision Diagnostics GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for One Step Pregnancy Test?

The FDA product code for One Step Pregnancy Test 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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Outros registros que listam Spd Swiss Precision Diagnostics GmbH como candidato(a)

K240025Clearblue® Early Detection Pregnancy Test K213379Clearblue ® Early Pregnancy Test K200913Clearblue® Early Digital Pregnancy Test

Dispositivos Relacionados (Código: LCX)

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., LLC K242135Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test MidstreamNanjing Synthgene Medical Technology Co., Ltd.K243573FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test MidstreamAssure Tech., LLC K241394iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test StripAndon Health 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.