510(k) K111778
K111778 is an FDA 510(k) premarket notification submitted by U.S Army Medical Materiel Development Activity for the device "JBAIDS INFLUENZA A SUBTYPING KIT". The FDA issued a decision of Substantially Equivalent on September 13, 2011. The device falls under product code OQW (2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification), a Class II device regulated under 21 CFR 866.3332. U.S Army Medical Materiel Development Activity has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 13, 2011
- Date Received
- June 23, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification
- Device Class
- Class II
- Regulation Number
- 866.3332
- Review Panel
- MI
- Submission Type
2009 H1N1 influenza virus detection and identification reagents are used to directly detect and differentiate the 2009 H1N1 influenza virus in human respiratory specimens