Careside Bun
FDA 510(k) K980057 · Exigent Diagnostics, Inc.
510(k) numberK980057
Submission
- Device name
- Careside Bun
- Applicant
- Exigent Diagnostics, Inc.
Culver City, CA, US - Received
- January 6, 1998
- Decision date
- February 5, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CDQ – Urease And Glutamic Dehydrogenase, Urea Nitrogen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1770
- Specialty
- Clinical Chemistry
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|---|---|---|---|
| K203771 | Urea Nitrogen2CDQ · Traditional | Abbott Ireland Diagnostics Division | 05/31/2022SE |
| K140690 | BS-480 Chemistry Analyzer, BS-490 Chemistry Analyzer, CLC720I Chemistry AnalyzerCDQ · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 09/02/2014SE |
| K110675 | Easyra Urea Nitrogen and Creatinine ReagentsCDQ · Traditional | Medica Corp. | 04/21/2011SE |
| K073295 | Urea/Bun, Scal, Nortrol, AbtrolCDQ · Traditional | Thermofisher Scientific OY | 05/29/2008SE |
| K070146 | Abx Pentra Glucose HK CP, Urea CP, Uric Acid CPCDQ · Traditional | Horiba Abx | 10/12/2007SE |
| K060120 | Teco CX3 Reagent Set for Synchron CX SystemCDQ · Traditional | Teco Diagnostics | 03/27/2006SE |
| K041051 | Raichem Bun Rate Reagent (Liquid)CDQ · Traditional | Hemagen Diagnostics, Inc. | 06/30/2004SE |
| K024182 | Precision Systems Analette Chemistry Analyzer Stanbio Laboratory ReagentsCDQ · Traditional | Precision Systems, Inc. | 03/03/2003SE |
| K021385 | Atac Pak Bun ReagentCDQ · Traditional | Elan Diagnostics | 07/12/2002SE |
| K012649 | Raichem Bun Rate ReagentCDQ · Traditional | Hemagen Diagnostics, Inc. | 10/15/2001SE |
More from Hemagen Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K982118 | Careside AnalyzerCHH · Traditional | 07/24/1998SE |
| K981899 | Careside Hdl-CholesterolLBS · Traditional | 07/14/1998SE |
| K981183 | Careside GlucoseCGA · Traditional | 05/07/1998SE |
| K980043 | Careside CreatinineJFY · Traditional | 03/30/1998SE |
| K980056 | Careside AnalyzerJJF · Traditional | 03/06/1998SE |
| K980042 | Careside Total ProteinCEK · Traditional | 02/04/1998SE |
| K980041 | Careside AlbuminCIX · Traditional | 02/04/1998SE |
| K980055 | Careside GlobulinJGE · Traditional | 01/28/1998SE |
Questions and answers
When was Careside Bun cleared by the FDA?
Careside Bun (K980057) received a 510(k) decision of Substantially Equivalent on February 5, 1998, 30 days after the submission was received.
What is the product code of K980057?
The FDA product code is CDQ – Urease And Glutamic Dehydrogenase, Urea Nitrogen, a Class II (moderate risk) device regulated under 21 CFR 862.1770.