510(k) K140851
- Device
- INFLUENZA A SUBTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
- Applicant
- CENTERS FOR DISEASE CONTROL AND PREVENTION
- 510(k) number
- K140851
- Product code
- OEP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-04-25
- Date received
- 2014-04-03
- Regulation
- 866.3980
- Classification name
- Influenza A Virus Subtype Differentiation Nucleic Acid Assay
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CDR YON YU, PHARM.D.
- Address
- 1600 Clifton Rd., Mailstop D-30 Atlanta GA US 30333 30333
FDA Registration Numbers#
- 3008632402
- 3003030793
- 1650733
- 3005360469
- 3038610665
- 3002773840
- 3006028115
- 3007799234
- 3002777243
- 3013019728
- 3006198300
Source Documents#
Legacy Summary#
summary
FDA Review#
Decision Summary