Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K132822
Device Classification Name
System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
More FDA Info for this Device
510(K) Number
K132822
Device Name
System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
Applicant
GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
2555 Boul. du Parc-Technologique
Quebec G1P 4S5 CA
Other 510(k) Applications for this Company
Contact
PATRICIA DIONNE
Other 510(k) Applications for this Contact
Regulation Number
866.1640
More FDA Info for this Regulation Number
Classification Product Code
NQX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/09/2013
Decision Date
11/26/2013
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact