EBNA ACIF ASSAY KIT— 510(k) K871298
Substantially EquivalentGranbio, Inc.
FDA 510(k) clearance K871298 for EBNA ACIF ASSAY KIT, Substantially Equivalent on 1987-06-25. Applicant: Granbio, Inc.. Device class: 1.
Clearance details
- Applicant
- Granbio, Inc.
- Product code
- Code LLM
- Device class
- Class 1
- Regulation
- 21 CFR 866.3235
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Temecula, CA, US
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