The following data is part of a premarket notification filed by Centers For Disease Control And Prevention (cdc) with the FDA for Cdc Human Influenza Virus Real- Time Rt-pcr Diagnostic Panel, Influenza A/h5 Subtyping.
| Device ID | K153148 |
| 510k Number | K153148 |
| Device Name: | CDC Human Influenza Virus Real- Time RT-PCR Diagnostic Panel, Influenza A/H5 Subtyping |
| Classification | Influenza A And Influenza B Multiplex Nucleic Acid Assay |
| Applicant | CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) 1600 CLIFTON ROAD, MS-C18 Atlanta, GA 30329 -4027 |
| Contact | Yon Yu |
| Correspondent | Yon Yu CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) 1600 CLIFTON ROAD, MS-C18 Atlanta, GA 30329 -4027 |
| 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 | 2015-10-30 |
| Decision Date | 2015-12-01 |
| Summary: | summary |