K203612 is an FDA 510(k) clearance for the Capture-CMV. This device is classified as a Antigen, Iha, Cytomegalovirus (Class II - Special Controls, product code LJO).
Submitted by Immucor, Inc. (Norcross, US). The FDA issued a Cleared decision on March 22, 2021, 102 days after receiving the submission on December 10, 2020.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3175.
| 510(k) Number | K203612 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 10, 2020 |
| Decision Date | March 22, 2021 |
| Days to Decision | 102 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | LJO - Antigen, Iha, Cytomegalovirus |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3175 |