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 Diagnostic Panel.
| Device ID | K123905 |
| 510k Number | K123905 |
| Device Name: | CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL |
| Classification | 2009 H1n1 Influenza Virus (swine Origin), Nucleic Acid Or Antigen, Detection And Identification |
| Applicant | CENTERS FOR DISEASE CONTROL AND PREVENTION 1600 CLIFTON RD. NE (MS C-18) Atlanta, GA 30333 |
| Contact | Hye-joo Kim, Pharm. D |
| Correspondent | Hye-joo Kim, Pharm. D CENTERS FOR DISEASE CONTROL AND PREVENTION 1600 CLIFTON RD. NE (MS C-18) Atlanta, GA 30333 |
| Product Code | OQW |
| Subsequent Product Code | NSU |
| Subsequent Product Code | NXD |
| Subsequent Product Code | OEP |
| CFR Regulation Number | 866.3332 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-19 |
| Decision Date | 2013-01-14 |
| Summary: | summary |