The following data is part of a premarket notification filed by Centers For Disease Control And Prevention with the FDA for Influenza B Lineage Genotyping Kit, Cdc Human Influenza Virus Real-time Rt-pcr Diagnostic Panel.
| Device ID | K140857 |
| 510k Number | K140857 |
| Device Name: | INFLUENZA B LINEAGE GENOTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL |
| Classification | Influenza A And Influenza B Multiplex Nucleic Acid Assay |
| Applicant | CENTERS FOR DISEASE CONTROL AND PREVENTION 1600 CLIFTON ROAD, MS-C18 Atlanta, GA 30333 |
| Contact | Cdr Yon Yu, Pharm.d. |
| Correspondent | Cdr Yon Yu, Pharm.d. CENTERS FOR DISEASE CONTROL AND PREVENTION 1600 CLIFTON ROAD, MS-C18 Atlanta, GA 30333 |
| Product Code | OZE |
| CFR Regulation Number | 866.3980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-03 |
| Decision Date | 2014-04-25 |
| Summary: | summary |