Abx Pentra Albumin CP, Abx Pentra Micro-Albumin CP, Abx Pentra Total Protein CP, Abx Pentra Multical
FDA 510(k) K060434 · Horiba Abx
510(k) numberK060434
Submission
- Device name
- Abx Pentra Albumin CP, Abx Pentra Micro-Albumin CP, Abx Pentra Total Protein CP, Abx Pentra Multical
- Applicant
- Horiba Abx
Montpellier, FR - Received
- February 21, 2006
- Decision date
- June 5, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CIX – Bromcresol Green Dye-Binding, Albumin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1035
- Specialty
- Clinical Chemistry
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Questions and answers
When was Abx Pentra Albumin CP, Abx Pentra Micro-Albumin CP, Abx Pentra Total Protein CP, Abx Pentra Multical cleared by the FDA?
Abx Pentra Albumin CP, Abx Pentra Micro-Albumin CP, Abx Pentra Total Protein CP, Abx Pentra Multical (K060434) received a 510(k) decision of Substantially Equivalent on June 5, 2007, 469 days after the submission was received.
What is the product code of K060434?
The FDA product code is CIX – Bromcresol Green Dye-Binding, Albumin, a Class II (moderate risk) device regulated under 21 CFR 862.1035.