Olympus Reply Urea Nitrogen Reagent
FDA 510(k) K931745 · Olympus Corp.
510(k) numberK931745
Submission
- Device name
- Olympus Reply Urea Nitrogen Reagent
- Applicant
- Olympus Corp.
Lake Success, NY, US - Received
- April 5, 1993
- Decision date
- August 19, 1993
- 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 Olympus Reply Urea Nitrogen Reagent cleared by the FDA?
Olympus Reply Urea Nitrogen Reagent (K931745) received a 510(k) decision of Substantially Equivalent on August 19, 1993, 136 days after the submission was received.
What is the product code of K931745?
The FDA product code is CDQ – Urease And Glutamic Dehydrogenase, Urea Nitrogen, a Class II (moderate risk) device regulated under 21 CFR 862.1770.