IDEIA HERPES SIMPLEX VIRUS TEST— 510(k) K871877
Substantially EquivalentBoots-Celltech Diagnostics, Inc.
FDA 510(k) clearance K871877 for IDEIA HERPES SIMPLEX VIRUS TEST, Substantially Equivalent on 1989-11-17. Applicant: Boots-Celltech Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Boots-Celltech Diagnostics, Inc.
- Product code
- Code LGC
- Device class
- Class 2
- Regulation
- 21 CFR 866.3305
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Berkshire, England, GB
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