K210254 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 September 1, 2021, 215 days after receiving the submission on January 29, 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 | K210254 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 29, 2021 |
| Decision Date | September 01, 2021 |
| Days to Decision | 215 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. |