FDA 510(k)
FDA class 2
Unknown
🇬🇧 United Kingdom
ConcizuTrace ELISA
K Number: DEN240035
·
Decision May 22, 2025
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
0
Applicant Total
116
Review Days
325
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Basic Information
- Device Name
- ConcizuTrace ELISA
- K Number
- DEN240035
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 864.7298
- Medical Specialty
- Hematology
- Decision
- Unknown
- Applicant
- Randox Laboratories, Ltd.
- Date Received
- July 1, 2024
- Decision Date
- May 22, 2025
- Product Code
- SES
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| SES | Non-Factor Replacement Product Test System | FDA class 2 | Hematology |
Other Clearances by Randox Laboratories, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K230890 | ISE Electrodes | Sep 8, 2023 | Substantially Equivalent |
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| 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 |
| K132090 | BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2 | Aug 8, 2013 | Substantially Equivalent |