FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIGOXIN ASSAY FOR THE TECCHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS
K Number: K951631
·
Decision Jun 9, 1995
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
19
Applicant Total
96
Review Days
63
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Basic Information
- Device Name
- DIGOXIN ASSAY FOR THE TECCHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS
- K Number
- K951631
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3300
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bayer Corp.
- Date Received
- April 7, 1995
- Decision Date
- June 9, 1995
- Product Code
- LFM
- 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 |
|---|---|---|---|
| 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
·Clinical Toxicology
RANDOX DIGITOXIN
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DGTX FLEX REAGENT CARTRIDGE, MODEL DF36
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FDA Class 2
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ACS DIGITOXIN
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ABBOTT AXSYM DIGITOXIN (MODIFY)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
AXSYM DIGITOXIN
FDA 510(k)
FDA Class 2
·Clinical Toxicology
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