BUN-300/BUN-500 Urea Nitrogen Reagent
FDA 510(k) K934533 · Horizon Diagnostics, Inc.
510(k) numberK934533
Submission
- Device name
- BUN-300/BUN-500 Urea Nitrogen Reagent
- Applicant
- Horizon Diagnostics, Inc.
Ann Arbor, MI, US - Received
- September 17, 1993
- Decision date
- November 26, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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More from Hemagen Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K971566 | Creatine Kinase-Mb Reagent SetCGS · Traditional | 07/14/1997SE |
| K933722 | Horizon Diagnostics Triglycerides-Gpo ReagentCDT · Traditional | 06/13/1996SE |
| K935712 | Iron/Tibc ReagentJIY · Traditional | 09/20/1995SE |
| K930678 | AmylaseJFJ · Traditional | 04/06/1994SE |
| K930679 | Direct BilirubinCIG · Traditional | 06/29/1993SE |
| K930074 | In-Vitro Diagnostic Reagent SetJGJ · Traditional | 05/11/1993SE |
Questions and answers
When was BUN-300/BUN-500 Urea Nitrogen Reagent cleared by the FDA?
BUN-300/BUN-500 Urea Nitrogen Reagent (K934533) received a 510(k) decision of Substantially Equivalent on November 26, 1993, 70 days after the submission was received.
What is the product code of K934533?
The FDA product code is CDQ – Urease And Glutamic Dehydrogenase, Urea Nitrogen, a Class II (moderate risk) device regulated under 21 CFR 862.1770.