The following data is part of a premarket notification filed by Center For Disease Control And Prevention (cdc) with the FDA for Cdc Human Influenza Virus Real-time Rt-pcr Diagnostic Panel, Influenza A/b Typing Kit.
| Device ID | K133869 |
| 510k Number | K133869 |
| Device Name: | CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/B TYPING KIT |
| Classification | Influenza A And Influenza B Multiplex Nucleic Acid Assay |
| Applicant | CENTER FOR DISEASE CONTROL AND PREVENTION (CDC) 1600 CLIFTON ROAD, MS-C18 Atlanta, GA 30333 |
| Contact | Hye-joo Kim |
| Correspondent | Hye-joo Kim CENTER FOR DISEASE CONTROL AND PREVENTION (CDC) 1600 CLIFTON ROAD, MS-C18 Atlanta, GA 30333 |
| Product Code | OZE |
| Subsequent Product Code | NSU |
| Subsequent Product Code | NXD |
| CFR Regulation Number | 866.3980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-20 |
| Decision Date | 2014-01-17 |
| Summary: | summary |