K213936 is an FDA 510(k) clearance for the LIAISON MeMed BV, LIAISON MeMed BV Control Set. This device is classified as a Immunoassay For Host Biomarkers Of Infection (Class II - Special Controls, product code QPS).
Submitted by DiaSorin, Inc. (Stillwater, US). The FDA issued a Cleared decision on July 14, 2022, 210 days after receiving the submission on December 16, 2021.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3215. A Semi-quantitative Immunoassay That Quantifies The Relative Levels Of Host Response Proteins Isolated From Serum Or Similar Specimens..
| 510(k) Number | K213936 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 16, 2021 |
| Decision Date | July 14, 2022 |
| Days to Decision | 210 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | QPS — Immunoassay For Host Biomarkers Of Infection |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3215 |
| Definition | A Semi-quantitative Immunoassay That Quantifies The Relative Levels Of Host Response Proteins Isolated From Serum Or Similar Specimens. |