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)

ACON ONE STEP HOME PREGNANCY TEST STRIP

K-Number: K993483 · 2000-01-20

ApplicantACON Laboratories, Inc.
Decision Date2000-01-20
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACON ONE STEP HOME PREGNANCY TEST STRIP is the device name listed in this FDA 510(k) record. The listed applicant is ACON Laboratories, Inc.. It received FDA 510(k) clearance on 2000-01-20 under 510(k) number K993483. 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 ACON ONE STEP HOME PREGNANCY TEST STRIP?

ACON ONE STEP HOME PREGNANCY TEST STRIP is a medical device that received FDA 510(k) clearance on 2000-01-20. The listed applicant is ACON Laboratories, Inc.. The 510(k) number is K993483.

When did ACON ONE STEP HOME PREGNANCY TEST STRIP receive FDA 510(k) clearance?

ACON ONE STEP HOME PREGNANCY TEST STRIP received FDA 510(k) clearance on 2000-01-20, under 510(k) number K993483.

Who is the listed applicant for ACON ONE STEP HOME PREGNANCY TEST STRIP?

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

What is the FDA product code for ACON ONE STEP HOME PREGNANCY TEST STRIP?

The FDA product code for ACON ONE STEP HOME PREGNANCY TEST STRIP 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 ACON Laboratories, Inc. 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.

K261212Flowflex Plus RSV + Flu A/B + COVID Rapid TestK251697Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test StripK251749Flowflex Plus RSV + Flu A/B + COVID Home TestK250085On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring SystemK250377Flowflex Plus COVID-19 + Flu A/B Home TestK232715Distinct® Digital Pregnancy Test

View all 81 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.

↑