IMAGEN RESPIRATORY SYNCYTIAL VIRUS TEST— 510(k) K854081
Substantially EquivalentBoots-Celltech Diagnostics, Inc.
FDA 510(k) clearance K854081 for IMAGEN RESPIRATORY SYNCYTIAL VIRUS TEST, Substantially Equivalent on 1986-01-03. Applicant: Boots-Celltech Diagnostics, Inc.. Device class: 1.
Clearance details
- Applicant
- Boots-Celltech Diagnostics, Inc.
- Product code
- Code GQG
- Device class
- Class 1
- Regulation
- 21 CFR 866.3480
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Berkshire, England, GB
Recent devices under product code GQG
view allMore clearances from Boots-Celltech Diagnostics, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.