Enzymatic Bun (Rate) Reagent Kit
FDA 510(k) K761261 · Beckman Instruments, Inc.
510(k) numberK761261
Submission
- Device name
- Enzymatic Bun (Rate) Reagent Kit
- Applicant
- Beckman Instruments, Inc.
Mchenry, IL, US - Received
- December 16, 1976
- Decision date
- December 29, 1976
- 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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| 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 |
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Questions and answers
When was Enzymatic Bun (Rate) Reagent Kit cleared by the FDA?
Enzymatic Bun (Rate) Reagent Kit (K761261) received a 510(k) decision of Substantially Equivalent on December 29, 1976, 13 days after the submission was received.
What is the product code of K761261?
The FDA product code is CDQ – Urease And Glutamic Dehydrogenase, Urea Nitrogen, a Class II (moderate risk) device regulated under 21 CFR 862.1770.