Yumizen C1200 ALP, Yumizen C1200 Albumin
FDA 510(k) K191245 · Horiba Abx SAS
510(k) numberK191245
Submission
- Device name
- Yumizen C1200 ALP, Yumizen C1200 Albumin
- Applicant
- Horiba Abx SAS
Montpellier Cedex 4, FR - Received
- May 9, 2019
- Decision date
- August 30, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CJE – Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1050
- Specialty
- Clinical Chemistry
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| K162275 | Randox RX Daytona Plus Alkaline Phosphatase (ALP)CJE · Traditional | Randox Laboratories Limited | 04/21/2017SE |
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| K191993 | Yumizen C1200 CRPDCK · Traditional | 10/03/2019SE |
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Questions and answers
When was Yumizen C1200 ALP, Yumizen C1200 Albumin cleared by the FDA?
Yumizen C1200 ALP, Yumizen C1200 Albumin (K191245) received a 510(k) decision of Substantially Equivalent on August 30, 2019, 113 days after the submission was received.
What is the product code of K191245?
The FDA product code is CJE – Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1050.