FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II
K Number: K153301
·
Decision Apr 8, 2016
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
84
Applicant Total
183
Review Days
147
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Basic Information
- Device Name
- Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II
- K Number
- K153301
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3320
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roche Diagnostics
- Date Received
- November 13, 2015
- Decision Date
- April 8, 2016
- Product Code
- KXT
- Advisory Committee
- Clinical Toxicology
- 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 |
|---|---|---|---|
| KXT | Enzyme Immunoassay, Digoxin | FDA class 2 | Clinical Toxicology |
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