K931520 is an FDA 510(k) clearance for the EPSTEIN-BARR VIRUS VCA (IGM) RECOMB IMMUN ANTIBODY. This device is classified as a Antibody Igm, If, Epstein-barr Virus (Class I - General Controls, product code LJN).
Submitted by Mrl Diagnostics (Cypress, US). The FDA issued a Cleared decision on April 26, 1994, 396 days after receiving the submission on March 26, 1993.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3235.
| 510(k) Number | K931520 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 26, 1993 |
| Decision Date | April 26, 1994 |
| Days to Decision | 396 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | LJN — Antibody Igm, If, Epstein-barr Virus |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3235 |