FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IL TEST(TM DIGOXIN
K Number: K914151
·
Decision Nov 29, 1991
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
84
Applicant Total
321
Review Days
74
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Basic Information
- Device Name
- IL TEST(TM DIGOXIN
- K Number
- K914151
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3320
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Instrumentation Laboratory CO
- Date Received
- September 16, 1991
- Decision Date
- November 29, 1991
- Product Code
- KXT
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- IM
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KXT), ordered by most recent decision date.
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ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01
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AXSYM DIGOXIN III
FDA 510(k)
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