IMAGEN CHLAMYDIA TEST— 510(k) K844683
Substantially EquivalentBoots-Celltech Diagnostics, Inc.
FDA 510(k) clearance K844683 for IMAGEN CHLAMYDIA TEST, Substantially Equivalent on 1985-02-06. Applicant: Boots-Celltech Diagnostics, Inc.. Device class: 1.
Clearance details
- Applicant
- Boots-Celltech Diagnostics, Inc.
- Product code
- Code IWP
- Device class
- Class 1
- Regulation
- 21 CFR 892.6500
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Berkshire, England, GB
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