K991459 is an FDA 510(k) clearance for the COPALIS EBV-M ANTIBODY ASSAY. This device is classified as a Antibody Igm, If, Epstein-barr Virus (Class I - General Controls, product code LJN).
Submitted by DiaSorin, Inc. (Columbia, US). The FDA issued a Cleared decision on May 14, 1999, 18 days after receiving the submission on April 26, 1999.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3235.
| 510(k) Number | K991459 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 26, 1999 |
| Decision Date | May 14, 1999 |
| Days to Decision | 18 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 |