Uric Acid
FDA 510(k) K981766 · Abbott Laboratories
510(k) numberK981766
Submission
- Device name
- Uric Acid
- Applicant
- Abbott Laboratories
Irving, TX, US - Received
- May 19, 1998
- Decision date
- June 19, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|---|
| K033278 | Randox Uric AcidCDO · Traditional | Randox Laboratories, Ltd. | 02/27/2004SE |
| 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 |
| 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 Uric Acid cleared by the FDA?
Uric Acid (K981766) received a 510(k) decision of Substantially Equivalent on June 19, 1998, 31 days after the submission was received.
What is the product code of K981766?
The FDA product code is CDO – Acid, Uric, Uricase (U.V.), a Class I (low risk) device regulated under 21 CFR 862.1775.