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510(k) Data Aggregation
K Number
K011525Manufacturer
Date Cleared
2001-07-16
(60 days)
Product Code
Regulation Number
862.1690Type
TraditionalPanel
Clinical ChemistryReference & Predicate Devices
N/A
Why did this record match?
Device Name :
SAFE AT HOME TSH (THYROID STIMULATING HORMONE BLOOD COLLECTION AND TRANSPORT SYSTEM)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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