K841520 is an FDA 510(k) clearance for the CMV LATEX AGGLUTINATION TEST KIT. This device is classified as a Antigen, Iha, Cytomegalovirus (Class II - Special Controls, product code LJO).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Walker, US). The FDA issued a Cleared decision on September 7, 1984, 148 days after receiving the submission on April 12, 1984.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3175.
| 510(k) Number | K841520 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 12, 1984 |
| Decision Date | September 07, 1984 |
| Days to Decision | 148 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | LJO — Antigen, Iha, Cytomegalovirus |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3175 |