FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIGOXIN RIABEAD DIAGNOSTIC KIT
K Number: K803075
·
Decision Dec 22, 1980
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
16
Applicant Total
883
Review Days
17
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Basic Information
- Device Name
- DIGOXIN RIABEAD DIAGNOSTIC KIT
- K Number
- K803075
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3320
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Abbott Laboratories
- Date Received
- December 5, 1980
- Decision Date
- December 22, 1980
- Product Code
- DON
- 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 |
|---|---|---|---|
| DON | Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep. | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DON), ordered by most recent decision date.
CIBA CORNING ACS DIGOXIN IMMUNOASSAY
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FDA Class 2
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CIBA CORNING MAGIC LITE DIGOXIN IMMUNOASSAY
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FDA Class 2
·Clinical Toxicology
MAGIC 125I DIGOXIN RADIOIMMUNOASSAY
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FDA Class 2
·Clinical Toxicology
PHASE II DIGOXIN RADIOIMMUNOASSAY KIT
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ZETAPHASE-DIG
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ENZYMUNE-TEST DIGOXIN
FDA 510(k)
FDA Class 2
·Clinical Toxicology
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