Alp S.C.E.
FDA 510(k) K863051 · J. D. Assoc.
510(k) numberK863051
Submission
- Device name
- Alp S.C.E.
- Applicant
- J. D. Assoc.
Montclair, NJ, US - Received
- August 12, 1986
- Decision date
- September 9, 1986
- 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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|---|---|---|---|
| K251074 | Tru Liver Health Test PanelCJE · Traditional | Truvian Health | 12/19/2025SE |
| K240468 | Alkaline PhosphataseCJE · Special | Abbott Laboratories Diagnostics Division | 10/16/2024SE |
| K223317 | Alkaline Phosphatase2CJE · Traditional | Abbott Ireland Diagnostics Division | 07/21/2023SE |
| K191245 | Yumizen C1200 ALP, Yumizen C1200 AlbuminCJE · Traditional | Horiba Abx SAS | 08/30/2019SE |
| K171971 | Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical…CJE · Traditional | Lite-On Technology Corp. H.S.P.B. | 01/25/2018SE |
| 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 |
|---|---|---|
| K863103 | Peg 6,000CHH · Traditional | 01/13/1987SE |
| K863054 | Ast S.C.E. (Got)CIT · Traditional | 01/13/1987SE |
| K863069 | MagnesiometerJGJ · Traditional | 12/31/1986SE |
| K863079 | CreatinkineticCGX · Traditional | 12/12/1986SE |
| K863112 | ProteinmeterJGP · Traditional | 12/10/1986SE |
| K863068 | LDH S.C.E.CFJ · Traditional | 12/10/1986SE |
| K863053 | Alt S.C.E. (GPT)CKA · Traditional | 12/10/1986SE |
| K863066 | TransfermeterJQF · Traditional | 12/04/1986SE |
| K863109 | FerrofastJIY · Traditional | 11/24/1986SE |
| K863102 | Glucometer-ECGA · Traditional | 11/24/1986SE |
Questions and answers
When was Alp S.C.E. cleared by the FDA?
Alp S.C.E. (K863051) received a 510(k) decision of Substantially Equivalent on September 9, 1986, 28 days after the submission was received.
What is the product code of K863051?
The FDA product code is CJE – Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1050.