FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS
K Number: K140436
·
Decision Dec 23, 2014
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
1
Applicant Total
45
Review Days
305
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Basic Information
- Device Name
- ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS
- K Number
- K140436
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1117
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fujirebio Diagnostics,Inc.
- Date Received
- February 21, 2014
- Decision Date
- December 23, 2014
- Product Code
- OSX
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OSX | Galectin-3 In Vitro Diagnostic Assay | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
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