Alkaline Phosphatase
FDA 510(k) K905684 · Amresco, Inc.
510(k) numberK905684
Submission
- Device name
- Alkaline Phosphatase
- Applicant
- Amresco, Inc.
Solon, OH, US - Received
- December 19, 1990
- Decision date
- December 28, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| K240468 | Alkaline PhosphataseCJE · Special | Abbott Laboratories Diagnostics Division | 10/16/2024SE |
| K223317 | Alkaline Phosphatase2CJE · Traditional | Abbott Ireland Diagnostics Division | 07/21/2023SE |
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| K171080 | ALP IFCC Gen.2CJE · Special | Roche Diagnostics Operations (Rdo) | 05/10/2017SE |
| K162275 | Randox RX Daytona Plus Alkaline Phosphatase (ALP)CJE · Traditional | Randox Laboratories Limited | 04/21/2017SE |
| 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 |
| K113436 | Ace Alkaline Phosphatase Reagent, Ace Amylase Reagent, Ace Ldh-L ReagentCJE · Traditional | Alfa Wassermann | 07/12/2012SE |
More from Alfa Wassermann
| 510(k) | Device | Decision |
|---|---|---|
| K905618 | GGT ReagentJPZ · Traditional | 02/26/1991SE |
| K904468 | Direct Bilirubin Reagent, 7776/7777/7576/7476/7176CIG · Traditional | 01/17/1991SE |
| K905544 | Magnesium ReagentJGJ · Traditional | 12/27/1990SE |
| K905284 | Hdl-Cholesterol Precipitant 7773/7573/7473/7173LBR · Traditional | 12/11/1990SE |
| K904004 | Amrescocreat Kinase Reagent 7716/17,7516,7416,7116CGS · Traditional | 12/11/1990SE |
| K905096 | GGT Reagents, 7738, 7739, 7538, 7438 & 7138JQB · Traditional | 11/28/1990SE |
| K904381 | Diazo Colorimentry Direct BilirubinCIG · Traditional | 10/12/1990SE |
| K903775 | Creatine PhosphokinaseCGS · Traditional | 10/04/1990SE |
| K903829 | Ast ReagentCIT · Traditional | 09/25/1990SE |
| K904007 | Bicarbonate Reagents Amresco Product #4326020KHS · Traditional | 09/13/1990SE |
Questions and answers
When was Alkaline Phosphatase cleared by the FDA?
Alkaline Phosphatase (K905684) received a 510(k) decision of Substantially Equivalent on December 28, 1990, 9 days after the submission was received.
What is the product code of K905684?
The FDA product code is CJE – Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1050.