Easytouch Bun Reagent Set
FDA 510(k) K832749 · Worthington Diagnostic Systems
510(k) numberK832749
Submission
- Device name
- Easytouch Bun Reagent Set
- Applicant
- Worthington Diagnostic Systems
Mchenry, IL, US - Received
- August 15, 1983
- Decision date
- October 14, 1983
- 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
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| 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 |
|---|---|---|
| K833708 | Compur* M1000 Hemoglobin & ErythrocyteLKZ · Traditional | 01/04/1984SE |
| K832785 | Compur* Easy Touch Uric Acid ReagentKNK · Traditional | 10/14/1983SE |
| K832748 | Compur* Easytouch Total BilirubinCIG · Traditional | 10/14/1983SE |
| K832427 | Easytouch Tromboplastin ReagentGJS · Traditional | 10/14/1983SE |
| K832750 | Easytouch Hemoglobin ReagentKHG · Traditional | 09/26/1983SE |
| K832426 | Easytouch Triglycerides Reagent SetCDT · Traditional | 09/12/1983SE |
| K831477 | Demand Analyzer SystemJJE · Traditional | 06/17/1983SE |
| K831318 | Compur* M1100 Hematrcrit SystemJPI · Traditional | 06/08/1983SE |
| K831227 | Compur Easy Touch Chemistry Analyzer-JJF · Traditional | 06/02/1983SE |
| K831103 | Tia-Igm Reagent & Calibrator SetsDFT · Traditional | 04/27/1983SE |
Questions and answers
When was Easytouch Bun Reagent Set cleared by the FDA?
Easytouch Bun Reagent Set (K832749) received a 510(k) decision of Substantially Equivalent on October 14, 1983, 60 days after the submission was received.
What is the product code of K832749?
The FDA product code is CDQ – Urease And Glutamic Dehydrogenase, Urea Nitrogen, a Class II (moderate risk) device regulated under 21 CFR 862.1770.