Alfa Wassermann, Inc.
Medical device manufacturer in West Caldwell, NJ.
9510(k) clearances
0PMA approvals
4recalls
Device types
- LCP Assay, Glycosylated Hemoglobin 1
- JFY Enzymatic Method, Creatinine 1
- MRR System, Test, Low Density, Lipoprotein 1
- CFJ Nad Reduction/Nadh Oxidation, Lactate… 1
- CHH Enzymatic Esterase--Oxidase, Cholesterol 1
- KHS Enzymatic, Carbon-Dioxide 1
- CJE Nitrophenylphosphate, Alkaline Phosphatase… 1
- CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt 1
- KLI Enzyme Immunoassay, Non-Radiolabeled, Total… 1
510(k) clearances
| 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 |
| K113436 | Ace Alkaline Phosphatase Reagent, Ace Amylase Reagent, Ace Ldh-L ReagentCJE · Traditional | 07/12/2012SE |
| 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 |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1530-2014 Class II | Alfa Wassermann Diagnostic Technologies, LLC. ACE AST Reagent. Product Usage: For…Extremely low absorbance readings. | 03/05/2014Terminated |
| Z-1529-2014 Class II | Alfa Wassermann Diagnostic Technologies, LLC. ACE ALT Reagent. Product Usage: For…Extremely low absorbance readings. | 03/05/2014Terminated |
| Z-0743-2013 Class II | Alfa Wassermann System Diluent 750 mL Manufactured for Alfa Wassermann Diagnostic…Inorganic phosphorus assays using System Diluent Lot 155599 may not product acceptable calibration results. | 10/10/2012Terminated |
| Z-0482-2009 | ACE and ACE Alera Hemoglobin A1C : EZA1C Reagent, EZA1C Controls, and EZA1C Calibrators.…Internal studies observed occasional unexpected outlier results in whole blood samples tested for Hemoglobin… | 08/22/2008Terminated |