FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇪 Ireland
RANDOX FERRITIN
K Number: K000662
·
Decision Apr 3, 2000
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
86
Applicant Total
116
Review Days
35
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- RANDOX FERRITIN
- K Number
- K000662
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5340
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Randox Laboratories, Ltd.
- Date Received
- February 28, 2000
- Decision Date
- April 3, 2000
- Product Code
- DBF
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| DBF | Ferritin, Antigen, Antiserum, Control | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DBF), ordered by most recent decision date.
LIAISON Ferritin
FDA 510(k)
FDA Class 2
·Immunology
Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor
FDA 510(k)
FDA Class 2
·Immunology
Atellica IM Ferritin Assay
FDA 510(k)
FDA Class 2
·Immunology
DIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIAZYME FERRITIN CONTROL SET
FDA 510(k)
FDA Class 2
·Immunology
K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR
FDA 510(k)
FDA Class 2
·Immunology
ADVIA CHEMISTRY FERRITIN (FRT) METHOD
FDA 510(k)
FDA Class 2
·Immunology
Other Clearances by Randox Laboratories, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| DEN240035 | ConcizuTrace ELISA | May 22, 2025 | Unknown |
| K230890 | ISE Electrodes | Sep 8, 2023 | Substantially Equivalent |
| K182042 | Randox Calcium (Ca) | Oct 23, 2018 | Substantially Equivalent |
| K162200 | Randox RX Daytona Plus Magnesium (MG) | Apr 28, 2017 | Substantially Equivalent |
| 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 |