ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS
FDA 510(k) K140436 · Fujirebio Diagnostics,Inc.
510(k) numberK140436
Submission
- Device name
- ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS
- Applicant
- Fujirebio Diagnostics,Inc.
Malvern, PA, US - Received
- February 21, 2014
- Decision date
- December 23, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OSX – Galectin-3 In Vitro Diagnostic Assay
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1117
- Specialty
- Clinical Chemistry
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.
Other 510(k)s with product code OSX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K093758 | BGM Galectin -3OSX · Traditional | Bg Medicine, Inc. | 11/17/2010SE |
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Questions and answers
When was ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS cleared by the FDA?
ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS (K140436) received a 510(k) decision of Substantially Equivalent on December 23, 2014, 305 days after the submission was received.
What is the product code of K140436?
The FDA product code is OSX – Galectin-3 In Vitro Diagnostic Assay, a Class II (moderate risk) device regulated under 21 CFR 862.1117.