Wiener Lab. Urea UV Cinetica Aa
FDA 510(k) K012260 · Wiener Laboratories Saic
510(k) numberK012260
Submission
- Device name
- Wiener Lab. Urea UV Cinetica Aa
- Applicant
- Wiener Laboratories Saic
Rosario, Santa Fe, AR - Received
- July 18, 2001
- Decision date
- September 19, 2001
- 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 Wiener Lab. Urea UV Cinetica Aa cleared by the FDA?
Wiener Lab. Urea UV Cinetica Aa (K012260) received a 510(k) decision of Substantially Equivalent on September 19, 2001, 63 days after the submission was received.
What is the product code of K012260?
The FDA product code is CDQ – Urease And Glutamic Dehydrogenase, Urea Nitrogen, a Class II (moderate risk) device regulated under 21 CFR 862.1770.