510(k) K133605
K133605 is an FDA 510(k) premarket notification submitted by Geneohm Sciences Canada, Inc. for the device "BD MAX MRSA XT, BD MAX INSTRUMENT". The FDA issued a decision of Substantially Equivalent on December 20, 2013. The device falls under product code NQX (System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen), a Class II device regulated under 21 CFR 866.1640. Geneohm Sciences Canada, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 20, 2013
- Date Received
- November 25, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
- Device Class
- Class II
- Regulation Number
- 866.1640
- Review Panel
- MI
- Submission Type
A nucleic acid amplification assay system (including probes, other reagents, and instrumentation) is an aid in the identification of MRSA colonization status for the prevention and control of MRSA infections in healthcare settings.