FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
DIGOXIN/RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT
K Number: K864449
·
Decision Feb 2, 1987
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
13
Applicant Total
4
Review Days
82
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Basic Information
- Device Name
- DIGOXIN/RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT
- K Number
- K864449
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3320
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Canadian Bioclinical, Ltd.
- Date Received
- November 12, 1986
- Decision Date
- February 2, 1987
- Product Code
- DPO
- 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 |
|---|---|---|---|
| DPO | Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep. | FDA class 2 | Clinical Toxicology |
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