K833014 is an FDA 510(k) clearance for the EBV-VCA-IGM IFA TEST SYSTEM. This device is classified as a Antibody Igm, If, Epstein-barr Virus (Class I - General Controls, product code LJN).
Submitted by Zeus Scientific, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 27, 1983, 112 days after receiving the submission on September 6, 1983.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.3235.
| 510(k) Number | K833014 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 06, 1983 |
| Decision Date | December 27, 1983 |
| Days to Decision | 112 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | LJN — Antibody Igm, If, Epstein-barr Virus |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3235 |