Cleared Traditional

LIFESIGN DXPRESS, MODEL LSR2000

K050955 · Princeton BioMeditech Corp. · Chemistry
Jan 2006
Decision
283d
Days
Class 2
Risk

About This 510(k) Submission

K050955 is an FDA 510(k) clearance for the LIFESIGN DXPRESS, MODEL LSR2000, a Visual, Pregnancy Hcg, Prescription Use (Class II — Special Controls, product code JHI), submitted by Princeton BioMeditech Corp. (Monmouth Junction, US). The FDA issued a Cleared decision on January 23, 2006, 283 days after receiving the submission on April 15, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K050955 FDA.gov
FDA Decision Cleared SESE
Date Received April 15, 2005
Decision Date January 23, 2006
Days to Decision 283 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JHI — Visual, Pregnancy Hcg, Prescription Use
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1155

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