FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ABBOTT AXSYM DIGITOXIN (MODIFY)
K Number: K963158
·
Decision Sep 10, 1996
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
19
Applicant Total
883
Review Days
46
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Basic Information
- Device Name
- ABBOTT AXSYM DIGITOXIN (MODIFY)
- K Number
- K963158
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3300
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abbott Laboratories
- Date Received
- July 26, 1996
- Decision Date
- September 10, 1996
- Product Code
- LFM
- 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 |
|---|---|---|---|
| LFM | Enzyme Immunoassay, Digitoxin | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LFM), ordered by most recent decision date.
DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE, PHENYTOIN, THEOPHYLLINE FLEX REAGENT CARTRIDGE
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FDA Class 2
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ACS DIGITOXIN
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FDA Class 2
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AXSYM DIGITOXIN
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DIGOXIN ASSAY FOR THE TECCHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
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