Velogene Genomic Identification Assay for Mrsa with One-Step Detection

FDA 510(k) K010858 · Id Biomedical Corp.

Substantially Equivalent

510(k) numberK010858

Submission

Device name
Velogene Genomic Identification Assay for Mrsa with One-Step Detection
Applicant
Id Biomedical Corp.
Bothell, WA, US
Received
March 22, 2001
Decision date
May 24, 2001
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MYI – System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies
Device class
Class II (moderate risk)
Regulation
21 CFR 866.1640
Specialty
Microbiology

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Questions and answers

When was Velogene Genomic Identification Assay for Mrsa with One-Step Detection cleared by the FDA?

Velogene Genomic Identification Assay for Mrsa with One-Step Detection (K010858) received a 510(k) decision of Substantially Equivalent on May 24, 2001, 63 days after the submission was received.

What is the product code of K010858?

The FDA product code is MYI – System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies, a Class II (moderate risk) device regulated under 21 CFR 866.1640.