EPSTEIN-BARR VIRUS EARLY ANTIGEN (EA) ANTIBODY TES— 510(k) K882447
Substantially EquivalentZeus Scientific, Inc.
FDA 510(k) clearance K882447 for EPSTEIN-BARR VIRUS EARLY ANTIGEN (EA) ANTIBODY TES, Substantially Equivalent on 1988-12-15. Applicant: Zeus Scientific, Inc.. Device class: 1.
Clearance details
- Applicant
- Zeus Scientific, 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
- Raritan, NJ, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.