SeptiCyte RAPID— 510(k) K232095

Substantially Equivalent

Immunexpress, Inc.

FDA 510(k) clearance K232095 for SeptiCyte RAPID, Substantially Equivalent on 2023-12-15. Applicant: Immunexpress, Inc..

Clearance details

Applicant: Immunexpress, Inc.
Product code: Code PRE
Advisory panel: Microbiology
Date received: 2023-07-13
Decision date: 2023-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.