FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENDAB DIGITOXIN ENZYME IMMUNOASSAY KIT
K Number: K802461
·
Decision Oct 31, 1980
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
2
Applicant Total
37
Review Days
23
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Basic Information
- Device Name
- ENDAB DIGITOXIN ENZYME IMMUNOASSAY KIT
- K Number
- K802461
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3300
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Immunotech Corp.
- Date Received
- October 8, 1980
- Decision Date
- October 31, 1980
- Product Code
- LCW
- 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 |
|---|---|---|---|
| LCW | Radioimmunoassay, Digitoxin (125-I) | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LCW), ordered by most recent decision date.
MATCHED COMPONENT SET FOR DIGITOXIN
FDA 510(k)
FDA Class 2
·Clinical Toxicology
(125 I) DIGITOXIN RIA KIT
FDA 510(k)
FDA Class 2
·Clinical Toxicology
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