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FDA 510(k), K140436, ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS
FDA 510(k), K140436, ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS
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510(K) Number: K140436
Device Name: ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS
Manufacturer: FUJIREBIO DIAGNOSTICS, INC.
Device Classification Name: galectin-3 in vitro diagnostic assay
Regulation Number: 862.1117
Classification Product Code: OSX
Date Received: 02/21/2014
Decision Date: 12/23/2014
Regulation Medical Specialty: Clinical Chemistry
Device Name: ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS
Manufacturer: FUJIREBIO DIAGNOSTICS, INC.
Device Classification Name: galectin-3 in vitro diagnostic assay
Regulation Number: 862.1117
Classification Product Code: OSX
Date Received: 02/21/2014
Decision Date: 12/23/2014
Regulation Medical Specialty: Clinical Chemistry
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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