Randox RX Daytona Plus Alkaline Phosphatase (ALP)
FDA 510(k) K162275 · Randox Laboratories Limited
510(k) numberK162275
Submission
- Device name
- Randox RX Daytona Plus Alkaline Phosphatase (ALP)
- Applicant
- Randox Laboratories Limited
Crumlin, GB - Received
- August 12, 2016
- Decision date
- April 21, 2017
- 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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| K131351 | Ace Alkaline Phosphatase Reagent, Amylase Reagent, Alt Reagent, Ast ReagentCJE · Traditional | Alfa Wassermann Diagnostic Technologies, LLC | 08/15/2013SE |
| K130141 | S Test Reagent Cartridge Alp (Alkaline Phosphatase)CJE · Traditional | Hitachi Chemical Diagnostics, Inc. | 03/22/2013SE |
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| K113269 | Elittech Clinical Systems Alp Ifcc SLCJE · Traditional | Elitechgroup | 12/29/2011SE |
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| K182042 | Randox Calcium (Ca)CJY · Traditional | 10/23/2018SE |
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Questions and answers
When was Randox RX Daytona Plus Alkaline Phosphatase (ALP) cleared by the FDA?
Randox RX Daytona Plus Alkaline Phosphatase (ALP) (K162275) received a 510(k) decision of Substantially Equivalent on April 21, 2017, 252 days after the submission was received.
What is the product code of K162275?
The FDA product code is CJE – Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1050.