Abx Pentra 400: Lipoproteins
FDA 510(k) K060854 · Horiba Abx
510(k) numberK060854
Submission
- Device name
- Abx Pentra 400: Lipoproteins
- Applicant
- Horiba Abx
Montpellier, FR - Received
- March 29, 2006
- Decision date
- August 24, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JIT – Calibrator, Secondary
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1150
- Specialty
- Clinical Chemistry
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| K163053 | Lumipulse G E2-III CalibratorsJIT · Abbreviated | Fujirebio Diagnostics,Inc. | 12/01/2016SE |
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Questions and answers
When was Abx Pentra 400: Lipoproteins cleared by the FDA?
Abx Pentra 400: Lipoproteins (K060854) received a 510(k) decision of Substantially Equivalent on August 24, 2006, 148 days after the submission was received.
What is the product code of K060854?
The FDA product code is JIT – Calibrator, Secondary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.