FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FAST DIGOXIN TEST SYSTEM
K Number: K924504
·
Decision Jan 13, 1993
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
84
Applicant Total
1
Review Days
131
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Basic Information
- Device Name
- FAST DIGOXIN TEST SYSTEM
- K Number
- K924504
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3320
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Diatron Corp.
- Date Received
- September 4, 1992
- Decision Date
- January 13, 1993
- Product Code
- KXT
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- 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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