Il Test(Tm) Urea Nitrogen
FDA 510(k) K914877 · Instrumentation Laboratory CO
510(k) numberK914877
Submission
- Device name
- Il Test(Tm) Urea Nitrogen
- Applicant
- Instrumentation Laboratory CO
Lexington, MA, US - Received
- October 29, 1991
- Decision date
- March 11, 1992
- 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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Questions and answers
When was Il Test(Tm) Urea Nitrogen cleared by the FDA?
Il Test(Tm) Urea Nitrogen (K914877) received a 510(k) decision of Substantially Equivalent on March 11, 1992, 134 days after the submission was received.
What is the product code of K914877?
The FDA product code is CDQ – Urease And Glutamic Dehydrogenase, Urea Nitrogen, a Class II (moderate risk) device regulated under 21 CFR 862.1770.