The following data is part of a premarket notification filed by Centers For Disease Control And Prevention with the FDA for Cdc Influenza 2009 A(h1n1)pdm Real-time Rt-pcr Panel.
| Device ID | K101564 |
| 510k Number | K101564 |
| Device Name: | CDC INFLUENZA 2009 A(H1N1)PDM REAL-TIME RT-PCR 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., N.E. MAILSTOP C-12 Atlanta, GA 30333 |
| Contact | Hye-joo Kim |
| Correspondent | Hye-joo Kim CENTERS FOR DISEASE CONTROL AND PREVENTION 1600 CLIFTON RD., N.E. MAILSTOP C-12 Atlanta, GA 30333 |
| Product Code | OQW |
| CFR Regulation Number | 866.3332 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-04 |
| Decision Date | 2010-06-22 |
| Summary: | summary |