Ultrachem Uric Acid Aldh, Item #65047
FDA 510(k) K812500 · Harleco
510(k) numberK812500
Submission
- Device name
- Ultrachem Uric Acid Aldh, Item #65047
- Applicant
- Harleco
Mchenry, IL, US - Received
- August 31, 1981
- Decision date
- September 23, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| 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 |
More from Em Diagnostic Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K820233 | Ultrazyme Plus Gamma GT(65055-65056)JQB · Traditional | 02/12/1982SE |
| K813427 | Ultrachem Gluc-DhLFR · Traditional | 12/31/1981SE |
| K813044 | Ultrachem Alb, Item #64970CIX · Traditional | 11/10/1981SE |
| K813043 | Ultrachem Crea Item #64972CGX · Traditional | 11/10/1981SE |
| K813042 | Ultrachem Gluc-Dh Set, Item #65048LFR · Traditional | 11/10/1981SE |
| K813041 | Ultrazyme-Gt, Item #64959 & 65032JQB · Traditional | 11/10/1981SE |
| K813040 | Ultrachem Ca, Item #64975CJY · Traditional | 11/10/1981SE |
| K813039 | Ultrachem E-Chol, Item #65025CHH · Traditional | 11/10/1981SE |
| K813038 | Ultrachem TP, Item #64974CEK · Traditional | 11/10/1981SE |
| K812594 | Ultra Zyme Plus Amyl #64982 & 65031CIJ · Traditional | 10/02/1981SE |
Questions and answers
When was Ultrachem Uric Acid Aldh, Item #65047 cleared by the FDA?
Ultrachem Uric Acid Aldh, Item #65047 (K812500) received a 510(k) decision of Substantially Equivalent on September 23, 1981, 23 days after the submission was received.
What is the product code of K812500?
The FDA product code is CDO – Acid, Uric, Uricase (U.V.), a Class I (low risk) device regulated under 21 CFR 862.1775.