Raichem Bun Rate Reagent
FDA 510(k) K012649 · Hemagen Diagnostics, Inc.
510(k) numberK012649
Submission
- Device name
- Raichem Bun Rate Reagent
- Applicant
- Hemagen Diagnostics, Inc.
Columbia, MD, US - Received
- August 13, 2001
- Decision date
- October 15, 2001
- 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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| 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 |
| K012260 | Wiener Lab. Urea UV Cinetica AaCDQ · Traditional | Wiener Laboratories Saic | 09/19/2001SE |
More from Wiener Laboratories Saic
| 510(k) | Device | Decision |
|---|---|---|
| K041052 | Raichem Glucose UV (Liquid)CFR · Traditional | 06/30/2004SE |
| K041051 | Raichem Bun Rate Reagent (Liquid)CDQ · Traditional | 06/30/2004SE |
| K041009 | Raichem Calcium (Ocpc) Liquid ReagentCIC · Traditional | 06/25/2004SE |
| K031101 | Raichem Assayed Control Serum Level 1 & 2JJY · Abbreviated | 06/16/2003SE |
| K023784 | Raichem HDL Cholesterol Using Cantrol HDL Precipitating Tubes on the Cobas Mira AnaylzerLBR · Special | 12/24/2002SE |
| K022772 | Raichem Ldl-Cholesterol Direct ReagentMRR · Traditional | 09/17/2002SE |
| K022767 | Raichem Lipid CalibratorJIX · Special | 09/03/2002SE |
| K021194 | Raichem CRP High Sensitivity Test SystemDCK · Traditional | 07/29/2002SE |
| K022049 | Modification to Raichem Calcium ReagentCJY · Special | 07/19/2002SE |
| K012668 | Raichem Glucose UV ReagentCFR · Traditional | 10/15/2001SE |
Questions and answers
When was Raichem Bun Rate Reagent cleared by the FDA?
Raichem Bun Rate Reagent (K012649) received a 510(k) decision of Substantially Equivalent on October 15, 2001, 63 days after the submission was received.
What is the product code of K012649?
The FDA product code is CDQ – Urease And Glutamic Dehydrogenase, Urea Nitrogen, a Class II (moderate risk) device regulated under 21 CFR 862.1770.