Search Results
Found 1 results
510(k) Data Aggregation
K Number
K111063Device Name
VITAL SERUM CONTROLS
Manufacturer
VITAL DIAGNOSTICS (MANUFACTURING) PTY. LTD.
Date Cleared
2011-06-28
(71 days)
Product Code
JJY
Regulation Number
862.1660Why did this record match?
Applicant Name (Manufacturer) :
VITAL DIAGNOSTICS (MANUFACTURING) PTY. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Vital Diagnostics Serum Controls are assayed multi-analyte quality control material. Vital Diagnostics Serum Controls are intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. An assayed quality control material may be used for proficiency testing in inter laboratory surveys.
Device Description
Not Found
Ask a Question
Page 1 of 1