K140436 is an FDA 510(k) clearance for the ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS. This device is classified as a Galectin-3 In Vitro Diagnostic Assay (Class II - Special Controls, product code OSX).
Submitted by Fujirebio Diagnostics,Inc. (Malvern, US). The FDA issued a Cleared decision on December 23, 2014, 305 days after receiving the submission on February 21, 2014.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1117. Galectin-3 Is Indicated For Use In Conjunction With Clinical Evaluation As An Aid In Assessing The Prognosis Of Patients Diagnosed With Chronic Heart Failure..
| 510(k) Number | K140436 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 21, 2014 |
| Decision Date | December 23, 2014 |
| Days to Decision | 305 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | OSX — Galectin-3 In Vitro Diagnostic Assay |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1117 |
| Definition | Galectin-3 Is Indicated For Use In Conjunction With Clinical Evaluation As An Aid In Assessing The Prognosis Of Patients Diagnosed With Chronic Heart Failure. |