FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GAMMA STICK GENTAMICIN RIA KIT
K Number: K800537
·
Decision Apr 24, 1980
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
18
Applicant Total
4
Review Days
45
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Basic Information
- Device Name
- GAMMA STICK GENTAMICIN RIA KIT
- K Number
- K800537
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3450
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Alpha Gamma Laboratory
- Date Received
- March 10, 1980
- Decision Date
- April 24, 1980
- Product Code
- DJB
- 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 |
|---|---|---|---|
| DJB | Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep. | FDA class 2 | Clinical Toxicology |
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