Ultrazyme Alkaline Phosphatase
FDA 510(k) K760024 · Harleco
510(k) numberK760024
Submission
- Device name
- Ultrazyme Alkaline Phosphatase
- Applicant
- Harleco
Mchenry, IL, US - Received
- June 14, 1976
- Decision date
- August 26, 1976
- 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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| 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 |
|---|---|---|
| K820233 | Ultrazyme Plus Gamma GT(65055-65056)JQB · Traditional | 02/12/1982SE |
| K813427 | Ultrachem Gluc-DhLFR · Traditional | 12/31/1981SE |
| K813044 | Ultrachem Alb, Item #64970CIX · Traditional | 11/10/1981SE |
| K813043 | Ultrachem Crea Item #64972CGX · Traditional | 11/10/1981SE |
| K813042 | Ultrachem Gluc-Dh Set, Item #65048LFR · Traditional | 11/10/1981SE |
| K813041 | Ultrazyme-Gt, Item #64959 & 65032JQB · Traditional | 11/10/1981SE |
| K813040 | Ultrachem Ca, Item #64975CJY · Traditional | 11/10/1981SE |
| K813039 | Ultrachem E-Chol, Item #65025CHH · Traditional | 11/10/1981SE |
| K813038 | Ultrachem TP, Item #64974CEK · Traditional | 11/10/1981SE |
| K812594 | Ultra Zyme Plus Amyl #64982 & 65031CIJ · Traditional | 10/02/1981SE |
Questions and answers
When was Ultrazyme Alkaline Phosphatase cleared by the FDA?
Ultrazyme Alkaline Phosphatase (K760024) received a 510(k) decision of Substantially Equivalent on August 26, 1976, 73 days after the submission was received.
What is the product code of K760024?
The FDA product code is CJE – Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1050.