FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CYBREX GENTAMICIN
K Number: K801084
·
Decision May 23, 1980
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
18
Applicant Total
883
Review Days
16
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Basic Information
- Device Name
- CYBREX GENTAMICIN
- K Number
- K801084
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3450
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Abbott Laboratories
- Date Received
- May 7, 1980
- Decision Date
- May 23, 1980
- Product Code
- LCQ
- 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 |
|---|---|---|---|
| LCQ | Fluorescent Immunoassay Gentamicin | FDA class 2 | Clinical Toxicology |
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