The following data is part of a premarket notification filed by Quidel Corp. with the FDA for Quick Vue Rsv Test, Models 20193, 20199.
| Device ID | K070747 |
| 510k Number | K070747 |
| Device Name: | QUICK VUE RSV TEST, MODELS 20193, 20199 |
| Classification | Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus |
| Applicant | QUIDEL CORP. 10165 MCKELLAR CT. San Diego, CA 92121 |
| Contact | Jennifer Hankard |
| Correspondent | Jennifer Hankard QUIDEL CORP. 10165 MCKELLAR CT. San Diego, CA 92121 |
| Product Code | GQG |
| CFR Regulation Number | 866.3480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-19 |
| Decision Date | 2007-04-23 |
| Summary: | summary |