Abx Pentra Glucose HK CP, Urea CP, Uric Acid CP
FDA 510(k) K070146 · Horiba Abx
510(k) numberK070146
Submission
- Device name
- Abx Pentra Glucose HK CP, Urea CP, Uric Acid CP
- Applicant
- Horiba Abx
Montpellier, FR - Received
- January 16, 2007
- Decision date
- October 12, 2007
- 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 Abx Pentra Glucose HK CP, Urea CP, Uric Acid CP cleared by the FDA?
Abx Pentra Glucose HK CP, Urea CP, Uric Acid CP (K070146) received a 510(k) decision of Substantially Equivalent on October 12, 2007, 269 days after the submission was received.
What is the product code of K070146?
The FDA product code is CDQ – Urease And Glutamic Dehydrogenase, Urea Nitrogen, a Class II (moderate risk) device regulated under 21 CFR 862.1770.