EPSTEIN-BARR VIRUS-NUCLEAR ANTIGEN— 510(k) K894626
Substantially EquivalentBion Ent., Ltd.
FDA 510(k) clearance K894626 for EPSTEIN-BARR VIRUS-NUCLEAR ANTIGEN, Substantially Equivalent on 1989-10-16. Applicant: Bion Ent., Ltd.. Device class: 1.
Clearance details
- Applicant
- Bion Ent., Ltd.
- 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
- Park Ridge, IL, US
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