IMAGEN(TM) CHLAMYDIA SPECIMEN COLLECTION KIT— 510(k) K862607
Substantially EquivalentBoots-Celltech Diagnostics, Inc.
FDA 510(k) clearance K862607 for IMAGEN(TM) CHLAMYDIA SPECIMEN COLLECTION KIT, Substantially Equivalent on 1986-08-04. Applicant: Boots-Celltech Diagnostics, Inc.. Device class: 1.
Clearance details
- Applicant
- Boots-Celltech Diagnostics, Inc.
- Product code
- Code LIO
- Device class
- Class 1
- Regulation
- 21 CFR 866.2900
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Berkshire, England, GB
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