K230944 is an FDA 510(k) clearance for the MeMed BV. This device is classified as a Immunoassay For Host Biomarkers Of Infection (Class II - Special Controls, product code QPS).
Submitted by MeMed Diagnostics, Ltd. (Tirat Carmel, IL). The FDA issued a Cleared decision on June 30, 2023, 87 days after receiving the submission on April 4, 2023.
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 | K230944 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 04, 2023 |
| Decision Date | June 30, 2023 |
| Days to Decision | 87 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. |