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510(k) Data Aggregation
K Number
K041665Device Name
L1-PRO SYSTEM
Manufacturer
Date Cleared
2004-07-23
(35 days)
Product Code
Regulation Number
878.4850Why did this record match?
Applicant Name (Manufacturer) :
PELIKAN TECHNOLOGIES, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The L1-Pro System is an automatic blood lancet device for multi-patient clinical use by a healthcare professional to obtain a capillary blood sample.
Device Description
The L1-Pro System is a handheld, battery powered electronic lancing system used by a healthcare professional to obtain capillary blood samples in multi-patient clinical use. It consists of three major components, a reusable lancing control unit called the launcher, a disposable lancet disk with multiple sterile lancets, and disposable sterile isolation strips.
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K Number
K024170Device Name
L1 SYSTEM
Manufacturer
Date Cleared
2003-04-14
(117 days)
Product Code
Regulation Number
878.4850Why did this record match?
Applicant Name (Manufacturer) :
PELIKAN TECHNOLOGIES, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The L1 System is an automatic blood lancet device used to obtain a capillary blood sample.
Device Description
Handheld, battery powered electronic lancing system for home use by individuals and caregivers to obtain blood samples.
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