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FDA 510(k) Application Details - K133605
Device Classification Name
System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
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510(K) Number
K133605
Device Name
System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
Applicant
GENEOHM SCIENCES CANADA, INC.
2555 BOUL. DU PARC-TECHNOLOGIQUE
QUEBEC G19 4S5 CA
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Contact
PATRICIA DIONNE
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Regulation Number
866.1640
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Classification Product Code
NQX
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Date Received
11/25/2013
Decision Date
12/20/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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