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510(k) Data Aggregation
K Number
K930683Device Name
EZTEST-GAS
Manufacturer
SGM BIOMEDICAL, INC.
Date Cleared
1997-03-04
(1483 days)
Product Code
FRC
Regulation Number
880.2800Why did this record match?
Applicant Name (Manufacturer) :
SGM BIOMEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
EZTest® - Gas self contained biological indicators are for monitoring the efficacy of ethylene oxide gas sterilization processors. Performance characteristics are established in accordance with USP XXIII for the 600mg/l process.
Device Description
The biological indicator consists of a self-contained unit which includes: bacterial spores inoculated onto a paper carrier, a small glass ampule containing sterile culture medium and color indicator, and a plastic vial that serves as the culture tube. This unit complies to the performance characteristics described in the USP XXIII.
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