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510(k) Data Aggregation
K Number
K103574Device Name
PREGNANCY ONE STEP RAPID TEST
Manufacturer
Lehnus & Associates Consulting
Date Cleared
2011-07-28
(234 days)
Product Code
LCX
Regulation Number
862.1155Why did this record match?
Applicant Name (Manufacturer) :
**Lehnus **& Associates Consulting
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Pregnancy One Step Rapid Test Strip is an in vitro diagnostic visual qualitative immunochromatographic assay designed for the rapid determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. For professional use only.
The Pregnancy One Step Rapid Test Cassette is an in vitro diagnostic visual qualitative immunochromatographic assay designed for the rapid determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. For professional use only.
The Pregnancy One Step Rapid Midstream Test is an in vitro diagnostic visual qualitative immunochromatographic assay designed for the rapid determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. For OTC self-testing use.
Device Description
Not Found
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K Number
K052359Device Name
IBL CORTISOL LIA TEST KIT
Manufacturer
Lehnus & Associates Consulting
Date Cleared
2005-10-03
(38 days)
Product Code
CGR
Regulation Number
862.1205Why did this record match?
Applicant Name (Manufacturer) :
**Lehnus **& Associates Consulting
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IBL Cortisol Luminescence Immunoassay is for the in-vitro-diagnostic quantitative determination of cortisol in human serum and saliva.
The Cortisol LIA kit is useful as an aid in the differential diagnosis of Cushing syndrome and Addison's disease.
Device Description
IBL Cortisol LIA test kit
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