Coulter Urea Nitrogen Reagent
FDA 510(k) K902175 · Coulter Corp.
510(k) numberK902175
Submission
- Device name
- Coulter Urea Nitrogen Reagent
- Applicant
- Coulter Corp.
Hialeah, FL, US - Received
- May 14, 1990
- Decision date
- June 12, 1990
- 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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| K012649 | Raichem Bun Rate ReagentCDQ · Traditional | Hemagen Diagnostics, Inc. | 10/15/2001SE |
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| K984216 | Immuno-Trol Control CellsJPK · Traditional | 03/16/1999SE |
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| K982172 | Cyto-Stat CD3-FITC/CD56-RDI Monoclonal Antibody Reagent with Cyto-Stat/Coulter Clone…GKZ · Traditional | 09/24/1998SE |
| K973634 | Coulter Ac.T Diff AnalyzerGKZ · Traditional | 10/29/1997SE |
Questions and answers
When was Coulter Urea Nitrogen Reagent cleared by the FDA?
Coulter Urea Nitrogen Reagent (K902175) received a 510(k) decision of Substantially Equivalent on June 12, 1990, 29 days after the submission was received.
What is the product code of K902175?
The FDA product code is CDQ – Urease And Glutamic Dehydrogenase, Urea Nitrogen, a Class II (moderate risk) device regulated under 21 CFR 862.1770.