FDA Product Code SCX: Immunoassay For Host Biomarkers Of Sepsis
A Semi-quantitative Immunoassay That Measures The Relative Levels Of Host Response Proteins Isolated From Host Blood Or Similar Specimens.
Leading manufacturers include Abionic SA.
1
Total
1
Cleared
264d
Avg days
2024
Since
Growing category -
1 submissions in the last 2 years
vs 0 in the prior period
FDA 510(k) Cleared Immunoassay For Host Biomarkers Of Sepsis Devices (Product Code SCX)
1 devices
About Product Code SCX - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code SCX since 2024, with 1 receiving FDA clearance (average review time: 264 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
SCX devices are reviewed by the Microbiology panel. Browse all Microbiology devices →