Urea Nitrogen (Bun) Liquid Reagent
FDA 510(k) K981106 · Teco Diagnostics
510(k) numberK981106
Submission
- Device name
- Urea Nitrogen (Bun) Liquid Reagent
- Applicant
- Teco Diagnostics
Anaheim, CA, US - Received
- March 26, 1998
- Decision date
- April 16, 1998
- 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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Questions and answers
When was Urea Nitrogen (Bun) Liquid Reagent cleared by the FDA?
Urea Nitrogen (Bun) Liquid Reagent (K981106) received a 510(k) decision of Substantially Equivalent on April 16, 1998, 21 days after the submission was received.
What is the product code of K981106?
The FDA product code is CDQ – Urease And Glutamic Dehydrogenase, Urea Nitrogen, a Class II (moderate risk) device regulated under 21 CFR 862.1770.