Randox Transferrin
FDA 510(k) K002585 · Randox Laboratories, Ltd.
510(k) numberK002585
Submission
- Device name
- Randox Transferrin
- Applicant
- Randox Laboratories, Ltd.
Crumlin, Co. Antrim, IE - Received
- August 21, 2000
- Decision date
- February 5, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DDG – Transferrin, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5880
- Specialty
- Immunology
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| 510(k) | Device | Decision |
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| K250741 | Evidence MultiSTAT DOA Urine MultiPlexDJG · Traditional | 01/23/2026SE |
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| K220451 | Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTATDJG · Traditional | 10/05/2023SE |
| K230890 | ISE ElectrodesCEM · Special | 09/08/2023SE |
| K182042 | Randox Calcium (Ca)CJY · Traditional | 10/23/2018SE |
| K162200 | Randox RX Daytona Plus Magnesium (MG)JGJ · Traditional | 04/28/2017SE |
| K162275 | Randox RX Daytona Plus Alkaline Phosphatase (ALP)CJE · Traditional | 04/21/2017SE |
| K161691 | Direct LDL Cholesterol (LDL)MRR · Traditional | 03/20/2017SE |
| K152085 | Liquid CO2-2 (LCO2-2)KHS · Traditional | 02/24/2016SE |
| K152343 | Direct BilirubinJFM · Traditional | 02/16/2016SE |
Questions and answers
When was Randox Transferrin cleared by the FDA?
Randox Transferrin (K002585) received a 510(k) decision of Substantially Equivalent on February 5, 2001, 168 days after the submission was received.
What is the product code of K002585?
The FDA product code is DDG – Transferrin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5880.