Urea Nitrogen (Bun) Liqui-Uv
FDA 510(k) K962418 · Stanbio Laboratory
510(k) numberK962418
Submission
- Device name
- Urea Nitrogen (Bun) Liqui-Uv
- Applicant
- Stanbio Laboratory
San Antonio, TX, US - Received
- June 24, 1996
- Decision date
- December 26, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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| K032936 | Direct LDL Cholesterol Liquid Color and Stanbio Direct Hdl/Ldl Cholesterol CalibratorJIX · Traditional | 03/12/2004SE |
| K032932 | Direct Hdl-Cholesterol Liquid Color; Direct Hdl/Ldl-Cholesterol CalibratorLBS · Traditional | 03/10/2004SE |
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Questions and answers
When was Urea Nitrogen (Bun) Liqui-Uv cleared by the FDA?
Urea Nitrogen (Bun) Liqui-Uv (K962418) received a 510(k) decision of Substantially Equivalent on December 26, 1996, 185 days after the submission was received.
What is the product code of K962418?
The FDA product code is CDQ – Urease And Glutamic Dehydrogenase, Urea Nitrogen, a Class II (moderate risk) device regulated under 21 CFR 862.1770.