K811262 is an FDA 510(k) clearance for the EPSTEIN-BARR VIRUS CAPSID ANTIGEN ANTI. This device is classified as a Antiserum, Fluorescent, Epstein-barr Virus (Class I - General Controls, product code JRY).
Submitted by Zeus Scientific, Inc. (Walker, US). The FDA issued a Cleared decision on May 27, 1981, 21 days after receiving the submission on May 6, 1981.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3235.
| 510(k) Number | K811262 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 06, 1981 |
| Decision Date | May 27, 1981 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JRY — Antiserum, Fluorescent, Epstein-barr Virus |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3235 |