MCE — Respiratory Syncytial Virus - Elisa Class I
FDA Device Classification
Classification Details
- Product Code
- MCE
- Device Class
- Class I
- Regulation Number
- 866.3480
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K061008 | quidel | QUICKVUE RSV (20 TEST KIT), MODEL 20193; (2 TEST KIT), MODEL 20199 | September 8, 2006 |
| K924289 | bio-rad laboratories | KALLESTAD RSV MICROPLATE EIA | February 12, 1993 |