The following data is part of a premarket notification filed by Quidel Corp. with the FDA for Quickvue Rsv (20 Test Kit), Model 20193; (2 Test Kit), Model 20199.
| Device ID | K061008 |
| 510k Number | K061008 |
| Device Name: | QUICKVUE RSV (20 TEST KIT), MODEL 20193; (2 TEST KIT), MODEL 20199 |
| Classification | Respiratory Syncytial Virus - Elisa |
| Applicant | QUIDEL CORP. 10165 MCKELLAR CT. San Diego, CA 92121 |
| Contact | John D Tamerius |
| Correspondent | John D Tamerius QUIDEL CORP. 10165 MCKELLAR CT. San Diego, CA 92121 |
| Product Code | MCE |
| CFR Regulation Number | 866.3480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-12 |
| Decision Date | 2006-09-08 |
| Summary: | summary |