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510(k) K062864

MASTALEX -MRSA, MODEL RST501 by Mast Group , Ltd. — Product Code MYI

K062864 is an FDA 510(k) premarket notification submitted by Mast Group , Ltd. for the device "MASTALEX -MRSA, MODEL RST501". The FDA issued a decision of Substantially Equivalent on October 18, 2006. The device falls under product code MYI (System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies), a Class II device regulated under 21 CFR 866.1640.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 2006
Date Received
September 25, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies
Device Class
Class II
Regulation Number
866.1640
Review Panel
MI
Submission Type

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FDA data resources