Bun
FDA 510(k) K781782 · Gilford Diagnostics
510(k) numberK781782
Submission
- Device name
- Bun
- Applicant
- Gilford Diagnostics
Mchenry, IL, US - Received
- October 19, 1978
- Decision date
- January 10, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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
Other 510(k)s with product code CDQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K832094 | Bilirubin Calibrators & ControlJIT · Traditional | 08/11/1983SE |
| K831844 | Direct Bilirubin ReagentCIG · Traditional | 07/18/1983SE |
| K831843 | Gilchem Total Bilirubin ReagentCIG · Traditional | 07/18/1983SE |
| K823709 | Triglyceride Reagent (UV)CDT · Traditional | 01/07/1983SE |
| K822739 | AhbdJMK · Traditional | 10/18/1982SE |
| K822334 | Bilirubin CalibratorsJIT · Traditional | 09/02/1982SE |
| K822289 | CO2/CI StandardsJIX · Traditional | 08/24/1982SE |
| K822149 | Gilchem Y-Gt ReagentJPZ · Traditional | 08/12/1982SE |
| K821719 | Ammonia ReagentJIF · Traditional | 06/24/1982SE |
| K820976 | Gil Chem Magnesium ReagentJGJ · Traditional | 04/26/1982SE |
Questions and answers
When was Bun cleared by the FDA?
Bun (K781782) received a 510(k) decision of Substantially Equivalent on January 10, 1979, 83 days after the submission was received.
What is the product code of K781782?
The FDA product code is CDQ – Urease And Glutamic Dehydrogenase, Urea Nitrogen, a Class II (moderate risk) device regulated under 21 CFR 862.1770.