EPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTEM— 510(k) K992587
Substantially EquivalentStellar Bio Systems, Inc.
FDA 510(k) clearance K992587 for EPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTEM, Substantially Equivalent on 1999-12-22. Applicant: Stellar Bio Systems, Inc.. Device class: 1.
Clearance details
- Applicant
- Stellar Bio Systems, Inc.
- Product code
- Code LSE
- Device class
- Class 1
- Regulation
- 21 CFR 866.3235
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Columbia, MD, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.