Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

FIRST RESPONSE(R) ONE-STEP

K-Number: K914304 · 1991-10-17

ApplicantArmkel, LLC
Decision Date1991-10-17
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FIRST RESPONSE(R) ONE-STEP is the device name listed in this FDA 510(k) record. The listed applicant is Armkel, LLC. It received FDA 510(k) clearance on 1991-10-17 under 510(k) number K914304. The device is classified under product code LCX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIRST RESPONSE(R) ONE-STEP?

FIRST RESPONSE(R) ONE-STEP is a medical device that received FDA 510(k) clearance on 1991-10-17. The listed applicant is Armkel, LLC. The 510(k) number is K914304.

When did FIRST RESPONSE(R) ONE-STEP receive FDA 510(k) clearance?

FIRST RESPONSE(R) ONE-STEP received FDA 510(k) clearance on 1991-10-17, under 510(k) number K914304.

Who is the listed applicant for FIRST RESPONSE(R) ONE-STEP?

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

What is the FDA product code for FIRST RESPONSE(R) ONE-STEP?

The FDA product code for FIRST RESPONSE(R) ONE-STEP is LCX.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Other records listing Armkel, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K040866FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TESTK030258FIRST RESPONSE PREGNANCY TESTK023405TROJAN MINT TINGLE BRAND LATEX CONDOMSK013433TROJAN PASSION BERRY GELK013614TROJAN CRYSTAL CLEAR LIQUIDK001212TROJAN EXTRA LARGE LATEX CONDOM

View all 68 devices →

Related Devices (Code: LCX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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., LLCK242135Synthgene 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., LLCK241394iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test StripAndon Health Co, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑