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)

ABBOTT BIOTELL PREGNANCY TEST

K-Number: K871996 · 1987-08-18

ApplicantAbbott Laboratories
Decision Date1987-08-18
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ABBOTT BIOTELL PREGNANCY TEST is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1987-08-18 under 510(k) number K871996. 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 ABBOTT BIOTELL PREGNANCY TEST?

ABBOTT BIOTELL PREGNANCY TEST is a medical device that received FDA 510(k) clearance on 1987-08-18. The listed applicant is Abbott Laboratories. The 510(k) number is K871996.

When did ABBOTT BIOTELL PREGNANCY TEST receive FDA 510(k) clearance?

ABBOTT BIOTELL PREGNANCY TEST received FDA 510(k) clearance on 1987-08-18, under 510(k) number K871996.

Who is the listed applicant for ABBOTT BIOTELL PREGNANCY TEST?

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

What is the FDA product code for ABBOTT BIOTELL PREGNANCY TEST?

The FDA product code for ABBOTT BIOTELL PREGNANCY TEST 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 Abbott Laboratories 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.

K262156Anti-HCV NextK252424Anti-HCV NextK243500ARCHITECT iGentamicinK243168Alinity i Rubella IgGK243283Alinity h-series SystemK233932Alinity i Toxo IgM

View all 876 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.

↑