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)

LIFESIGN DXPRESS, MODEL LSR2000

K-Number: K050955 · 2006-01-23

ApplicantPrinceton BioMeditech Corp.
Decision Date2006-01-23
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LIFESIGN DXPRESS, MODEL LSR2000 is the device name listed in this FDA 510(k) record. The listed applicant is Princeton BioMeditech Corp.. It received FDA 510(k) clearance on 2006-01-23 under 510(k) number K050955. The device is classified under product code JHI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIFESIGN DXPRESS, MODEL LSR2000?

LIFESIGN DXPRESS, MODEL LSR2000 is a medical device that received FDA 510(k) clearance on 2006-01-23. The listed applicant is Princeton BioMeditech Corp.. The 510(k) number is K050955.

When did LIFESIGN DXPRESS, MODEL LSR2000 receive FDA 510(k) clearance?

LIFESIGN DXPRESS, MODEL LSR2000 received FDA 510(k) clearance on 2006-01-23, under 510(k) number K050955.

Who is the listed applicant for LIFESIGN DXPRESS, MODEL LSR2000?

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

What is the FDA product code for LIFESIGN DXPRESS, MODEL LSR2000?

The FDA product code for LIFESIGN DXPRESS, MODEL LSR2000 is JHI.

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 Princeton BioMeditech Corp. 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.

K251538Status™ COVID-19/Flu A&BK182157BioSign Flu A+BK133474BIOSIGN FLU A + B, STATUS FLU A & BK132465BIOSIGN FLU A + B, STATUS FLU A & BK083746BIOSIGN FLU A+BK100817BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST

View all 71 devices →

Related Devices (Code: JHI)

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.

K262299Instant-View® hCG Combo II Cassette TestAlfa Scientific Designs, Inc.K241919Innovita HCG Pregnancy Rapid Combo TestInnovita (Tangshan) Biological Technology Co., Ltd.K203272Alltest Pregnancy Rapid Combo Test CassetteHangzhou AllTest Biotech Co., Ltd.K172322Atellica IM Total hCG (ThCG)Siemens Healthcare Diagnostics, Inc.K172257TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)True Diagnostics, Inc.K152768Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test StripAssure Tech. 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.

↑