FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇪 Ireland
RANDOX GENTAMICIN
K Number: K012978
·
Decision Sep 18, 2001
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
36
Applicant Total
116
Review Days
74
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Basic Information
- Device Name
- RANDOX GENTAMICIN
- K Number
- K012978
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3450
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Randox Laboratories, Ltd.
- Date Received
- July 6, 2001
- Decision Date
- September 18, 2001
- Product Code
- LCD
- 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 |
|---|---|---|---|
| LCD | Enzyme Immunoassay, Gentamicin | FDA class 2 | Clinical Toxicology |
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|---|---|---|---|
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| K152085 | Liquid CO2-2 (LCO2-2) | Feb 24, 2016 | Substantially Equivalent |
| K153435 | Direct HDL Cholesterol (HDL) | Jan 8, 2016 | Substantially Equivalent |
| K150654 | Cholesterol | Sep 29, 2015 | Substantially Equivalent |
| K131554 | RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENT | Jan 9, 2014 | Substantially Equivalent |
| K123977 | RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR | Nov 21, 2013 | Substantially Equivalent |
| K132156 | RANDOX CSF CONTROLS LEVELS 2 AND 3 | Oct 23, 2013 | Substantially Equivalent |