INCSTAR EPSTEIN-BARR NUCLEAR ANTIGEN (EBNA_ IGG ELISA KIT— 510(k) K946158
Substantially EquivalentIncstar Corp.
FDA 510(k) clearance K946158 for INCSTAR EPSTEIN-BARR NUCLEAR ANTIGEN (EBNA_ IGG ELISA KIT, Substantially Equivalent on 1995-06-09. Applicant: Incstar Corp.. Device class: 1.
Clearance details
- Applicant
- Incstar Corp.
- 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
- Stillwater, MN, US
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