Randox Microalbumin
FDA 510(k) K002674 · Randox Laboratories, Ltd.
510(k) numberK002674
Submission
- Device name
- Randox Microalbumin
- Applicant
- Randox Laboratories, Ltd.
Crumlin, Co. Antrim, IE - Received
- August 28, 2000
- Decision date
- October 5, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DDZ – Albumin, Fitc, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5040
- Specialty
- Immunology
Other 510(k)s with product code DDZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K050576 | Microalbumin Tia Reagent; Malb Calibrator Set 200; Malb Control-L, Control-HDDZ · Traditional | Good Biotech Corp. | 04/21/2005SE |
| K023860 | Microalbumin Reagent Set and CalibratorsDDZ · Traditional | Pointe Scientific, Inc., | 04/28/2003SE |
| K831902 | Fluorescein Conjugated Immunoglobin-DDZ · Traditional | Dako Corp. | 07/18/1983SE |
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Questions and answers
When was Randox Microalbumin cleared by the FDA?
Randox Microalbumin (K002674) received a 510(k) decision of Substantially Equivalent on October 5, 2000, 38 days after the submission was received.
What is the product code of K002674?
The FDA product code is DDZ – Albumin, Fitc, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5040.