K882447 is an FDA 510(k) clearance for the EPSTEIN-BARR VIRUS EARLY ANTIGEN (EA) ANTIBODY TES. This device is classified as a Epstein-barr Virus, Other (Class I - General Controls, product code LSE).
Submitted by Zeus Scientific, Inc. (Raritan, US). The FDA issued a Cleared decision on December 15, 1988, 184 days after receiving the submission on June 14, 1988.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3235.
| 510(k) Number | K882447 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 14, 1988 |
| Decision Date | December 15, 1988 |
| Days to Decision | 184 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | LSE — Epstein-barr Virus, Other |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3235 |