FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CEDIA DIGOXIN CR ASSAY
K Number: K872583
·
Decision Aug 28, 1987
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
84
Applicant Total
107
Review Days
59
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Basic Information
- Device Name
- CEDIA DIGOXIN CR ASSAY
- K Number
- K872583
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3320
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Microgenics Corp.
- Date Received
- June 30, 1987
- Decision Date
- August 28, 1987
- 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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