Dart Urea Nitrogen
FDA 510(k) K894836 · Coulter Electronics, Inc.
510(k) numberK894836
Submission
- Device name
- Dart Urea Nitrogen
- Applicant
- Coulter Electronics, Inc.
Hialeah, FL, US - Received
- July 31, 1989
- Decision date
- October 30, 1989
- 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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Questions and answers
When was Dart Urea Nitrogen cleared by the FDA?
Dart Urea Nitrogen (K894836) received a 510(k) decision of Substantially Equivalent on October 30, 1989, 91 days after the submission was received.
What is the product code of K894836?
The FDA product code is CDQ – Urease And Glutamic Dehydrogenase, Urea Nitrogen, a Class II (moderate risk) device regulated under 21 CFR 862.1770.