510kDecisions.com

FDA 510(k) Application Details - K111507

Device Classification Name 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification

  More FDA Info for this Device
510(K) Number K111507
Device Name 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification
Applicant CENTERS FOR DISEASE CONTROL AND PREVENTION
1600 CLIFTON RD. MS-C12
ATLANTA, GA US
Other 510(k) Applications for this Company
Contact CAPT HYE-JOO KIM, PHARM.D.
Other 510(k) Applications for this Contact
Regulation Number 866.3332

  More FDA Info for this Regulation Number
Classification Product Code OQW
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 06/01/2011
Decision Date 08/23/2011
Decision CS -
Classification Advisory Committee MI - Microbiology
Review Advisory Committee MI - Microbiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review N



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact