ANTI-EPSTEIN-BARR VIRUS KIT— 510(k) K842662
Substantially EquivalentAmico Lab, Inc.
FDA 510(k) clearance K842662 for ANTI-EPSTEIN-BARR VIRUS KIT, Substantially Equivalent on 1985-12-12. Applicant: Amico Lab, Inc.. Device class: 1.
Clearance details
- Applicant
- Amico Lab, Inc.
- Product code
- Code GNP
- Device class
- Class 1
- Regulation
- 21 CFR 866.3235
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- TN, US
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