PRESAGE ST2 ASSAY— 510(k) K111452

Name: FDA 510(k) clearance K111452
Creator: U.S. Food and Drug Administration
Published: 2011-12-09

Substantially Equivalent

Critical Care Diagnostics, Inc. (Dba Critical Diag

FDA 510(k) clearance K111452 for PRESAGE ST2 ASSAY, Substantially Equivalent on 2011-12-09. Applicant: Critical Care Diagnostics, Inc. (Dba Critical Diag. Device class: 2.

Clearance details

Applicant: Critical Care Diagnostics, Inc. (Dba Critical Diag
Product code: Code OYG
Device class: Class 2
Regulation: 21 CFR 862.1117
Advisory panel: Clinical Chemistry
Date received: 2011-05-25
Decision date: 2011-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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