The following data is part of a premarket notification filed by Centers For Disease Control And Prevention with the FDA for Cdc Human Influenza Virus Real-time Rt- Pcr Detection And Characterization Panel.
| Device ID | K080570 |
| 510k Number | K080570 |
| Device Name: | CDC HUMAN INFLUENZA VIRUS REAL-TIME RT- PCR DETECTION AND CHARACTERIZATION PANEL |
| Classification | Nucleic Acid Amplification, Novel Influenza A Virus, A/h5 (asian Lineage) Rna |
| Applicant | CENTERS FOR DISEASE CONTROL AND PREVENTION 1600 CLIFTON RD.,MS-C12 Atlanta, GA 30333 |
| Contact | Stephen Lindstrom |
| Correspondent | Stephen Lindstrom CENTERS FOR DISEASE CONTROL AND PREVENTION 1600 CLIFTON RD.,MS-C12 Atlanta, GA 30333 |
| Product Code | NXD |
| CFR Regulation Number | 866.3332 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-29 |
| Decision Date | 2008-09-30 |
| Summary: | summary |