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510(k) K050955

LIFESIGN DXPRESS, MODEL LSR2000 by Princeton BioMeditech Corp. — Product Code JHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 2006
Date Received
April 15, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Visual, Pregnancy Hcg, Prescription Use
Device Class
Class II
Regulation Number
862.1155
Review Panel
CH
Submission Type

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