Randox Uric Acid
FDA 510(k) K033278 · Randox Laboratories, Ltd.
510(k) numberK033278
Submission
- Device name
- Randox Uric Acid
- Applicant
- Randox Laboratories, Ltd.
Crumlin, GB - Received
- October 10, 2003
- Decision date
- February 27, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CDO – Acid, Uric, Uricase (U.V.)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1775
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CDO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K992798 | Sigma Diagnostics Infinity Uric Acid Reagent, Models 684-25, 684-100P, 684-500P…CDO · Traditional | Sigma Diagnostics, Inc. | 09/28/1999SE |
| K982251 | Sigma Diagnostics Infinity Uric Acid Reagent KitCDO · Traditional | Sigma Diagnostics, Inc. | 08/18/1998SE |
| K981766 | Uric AcidCDO · Traditional | Abbott Laboratories | 06/19/1998SE |
| K981189 | Uric AcidCDO · Traditional | Abbott Laboratories | 05/07/1998SE |
| K971485 | Uric Acid - Incorporating Dynamic Stabilization Technology - (DST)CDO · Traditional | Trace America, Inc. | 05/27/1997SE |
| K955752 | Olympus Uric Acid ReagentCDO · Traditional | Olympus America, Inc. | 01/31/1996SE |
| K932162 | Uric Acid Test Item Number 65422CDO · Traditional | Em Diagnostic Systems, Inc. | 09/27/1993SE |
| K923765 | Systemate Uricacid Test, Technicon Ra 1000CDO · Traditional | Em Diagnostic Systems, Inc. | 09/22/1992SE |
| K903335 | Systemate Uric Acid (Urca) Item Number 65422CDO · Traditional | Em Diagnostic Systems, Inc. | 08/17/1990SE |
| K875320 | Biotrol Uric Acid Enzymatique UV H.P.CDO · Traditional | Biotrol, USA, Inc. | 02/01/1988SE |
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Questions and answers
When was Randox Uric Acid cleared by the FDA?
Randox Uric Acid (K033278) received a 510(k) decision of Substantially Equivalent on February 27, 2004, 140 days after the submission was received.
What is the product code of K033278?
The FDA product code is CDO – Acid, Uric, Uricase (U.V.), a Class I (low risk) device regulated under 21 CFR 862.1775.