Olympus Uric Acid Reagent
FDA 510(k) K955752 · Olympus America, Inc.
510(k) numberK955752
Submission
- Device name
- Olympus Uric Acid Reagent
- Applicant
- Olympus America, Inc.
Melville, NY, US - Received
- December 19, 1995
- Decision date
- January 31, 1996
- 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 |
|---|---|---|---|
| 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 |
| 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 |
| 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 |
More from Biotrol, USA, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K111788 | Endoeye HD IIHET · Traditional | 01/13/2012SE |
| K081615 | Olympus Cea - Carcinoembryonic AntigenDHX · Traditional | 03/18/2009SE |
| K073490 | Olympus Igg ReagentCFN · Traditional | 02/11/2008SE |
| K073489 | Olympus Iga ReagentCFN · Traditional | 02/11/2008SE |
| K073487 | Olympus Igm ReagentCFN · Traditional | 02/11/2008SE |
| K062862 | Olympus Uric Acid Reagent, Model OSR6X98KNK · Traditional | 04/06/2007SE |
| K063804 | Olympus Triglyceride Test SystemCDT · Traditional | 03/23/2007SE |
| K061499 | OsferionMQV · Traditional | 01/26/2007SE |
| K062581 | Olympus TSH Reagent, Calibrator and Control and AU3000I Immunoassay SystemJLW · Traditional | 11/29/2006SE |
| K061575 | Olympus Calcium Arsenazo Reagent, OSR60117, OSR61117, OSR65117CJY · Traditional | 10/05/2006SE |
Questions and answers
When was Olympus Uric Acid Reagent cleared by the FDA?
Olympus Uric Acid Reagent (K955752) received a 510(k) decision of Substantially Equivalent on January 31, 1996, 43 days after the submission was received.
What is the product code of K955752?
The FDA product code is CDO – Acid, Uric, Uricase (U.V.), a Class I (low risk) device regulated under 21 CFR 862.1775.