Ace Alkaline Phosphatase Reagent, Ace Amylase Reagent, Ace Ldh-L Reagent
FDA 510(k) K113436 · Alfa Wassermann
510(k) numberK113436
Submission
- Device name
- Ace Alkaline Phosphatase Reagent, Ace Amylase Reagent, Ace Ldh-L Reagent
- Applicant
- Alfa Wassermann
West Caldwell, NJ, US - Received
- November 21, 2011
- Decision date
- July 12, 2012
- 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
Other 510(k)s with product code CJE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K113269 | Elittech Clinical Systems Alp Ifcc SLCJE · Traditional | Elitechgroup | 12/29/2011SE |
More from Elitechgroup
| 510(k) | Device | Decision |
|---|---|---|
| K131515 | Ace -Gt Reagent; Ace Lipase Ragent; Ace T4 ReagentKLI · Traditional | 08/14/2013SE |
| K113382 | Ace Alt ReagentCKA · Traditional | 07/19/2012SE |
| K113435 | Ace Carbon DIOXIDE(CO2-LC) Reagent, Ace Direct Bilirubin Reagent, Ace Total Bilirubin…KHS · Traditional | 07/02/2012SE |
| K091413 | S-Test Cholesterol (Cho), Model RC0009, S-Test HDL Cholesterol (HDL), Model RC0015…CHH · Traditional | 10/26/2009SE |
| K091544 | S-Test Lactate Dehydrogenase (LD), Model RC 0017CFJ · Traditional | 09/09/2009SE |
| K091333 | S-Test LDL Cholesterol (LDL), Model RC0022MRR · Traditional | 08/03/2009SE |
| K080073 | S-Test Creatinine (Cre)JFY · Traditional | 06/30/2008SE |
| K063306 | Ace Hemoglobin A1C Reagent, Model ACI-21, Hemoglobin A1C Calibrators, Model S2-72…LCP · Traditional | 04/17/2007SE |
Questions and answers
When was Ace Alkaline Phosphatase Reagent, Ace Amylase Reagent, Ace Ldh-L Reagent cleared by the FDA?
Ace Alkaline Phosphatase Reagent, Ace Amylase Reagent, Ace Ldh-L Reagent (K113436) received a 510(k) decision of Substantially Equivalent on July 12, 2012, 234 days after the submission was received.
What is the product code of K113436?
The FDA product code is CJE – Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1050.