FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GAMMA STICK 125-1 TOBRAMYCIN RIA KIT
K Number: K810011
·
Decision Jan 28, 1981
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
22
Applicant Total
4
Review Days
23
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Basic Information
- Device Name
- GAMMA STICK 125-1 TOBRAMYCIN RIA KIT
- K Number
- K810011
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3900
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Alpha Gamma Laboratory
- Date Received
- January 5, 1981
- Decision Date
- January 28, 1981
- Product Code
- KLB
- 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 |
|---|---|---|---|
| KLB | Radioimmunoassay, Tobramycin | FDA class 2 | Clinical Toxicology |
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