Company ยท US
Alfa Wassermann, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2007 to 2013. Name variants (Inc, Corp, punctuation) are merged.
9510(k) clearances (0 in 12 months)
5recalls (0 in 12 months)
5recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 2 |
| LCP | Assay, Glycosylated Hemoglobin | 2 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 1 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 1 |
| JFY | Enzymatic Method, Creatinine | 1 |
| JIX | Calibrator, Multi-Analyte Mixture | 1 |
| KHS | Enzymatic, Carbon-Dioxide | 1 |
| KLI | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | 1 |
| MRR | System, Test, Low Density, Lipoprotein | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 14, 2013 | K131515 | ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT Alfa Wassermann | KLI |
| Jul 19, 2012 | K113382 | ACE ALT REAGENT Alfa Wassermann | CKA |
| Jul 12, 2012 | K113436 | ACE ALKALINE PHOSPHATASE REAGENT, ACE AMYLASE REAGENT, ACE LDH-L REAGENT Alfa Wassermann | CJE |
| Jul 2, 2012 | K113435 | ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT Alfa Wassermann | KHS |
| Oct 26, 2009 | K091413 | S-TEST CHOLESTEROL (CHO), MODEL RC0009, S-TEST HDL CHOLESTEROL (HDL), MODEL RC0015, S-TEST TRIGLYCERIDES (TG) Alfa Wassermann, Inc. | CHH |
| Sep 9, 2009 | K091544 | S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017 Alfa Wassermann, Inc. | CFJ |
| Aug 3, 2009 | K091333 | S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022 Alfa Wassermann, Inc. | MRR |
| Jun 30, 2008 | K080073 | S-TEST CREATININE (CRE) Alfa Wassermann, Inc. | JFY |
| Apr 17, 2007 | K063306 | ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72 Alfa Wassermann, Inc. | LCP |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 30, 2014 | Alfa Wassermann, Inc. Alfa Wassermann Diagnostic Technologies, LLC. ACE AST Reagent.
Product Usage: For quantitative determination of AST in serum and lithium heparin plasma using ACE, ACE Alera and ACE Axcel Clinical Terminated |
CIT | K113382 |
| Apr 30, 2014 | Alfa Wassermann, Inc. Alfa Wassermann Diagnostic Technologies, LLC. ACE ALT Reagent.
Product Usage: For quantitative determination of ALT in serum and lithium heparin plasma using ACE, ACE Alera and ACE Axcel Clinical Terminated |
CKA | K131351 |
| Jan 28, 2013 | Alfa Wassermann, Inc. Alfa Wassermann System Diluent 750 mL
Manufactured for Alfa Wassermann Diagnostic Technologies LLC 4 Henderson Drive West Caldwell, NJ 07006
Alfa Wassermann B.V. Pompmolenlaan 24
3447 GK, Woerden T Terminated |
CEO | K103615 |
| Dec 17, 2008 | Alfa Wassermann, Inc. ACE and ACE Alera Hemoglobin A1C : EZA1C Reagent, EZA1C Controls, and EZA1C Calibrators.
Hemoglobin A1c (EZA1c) Calibrators for Calibration of the Enzymatic Hemoglobin A1c (HbA1c) Assay. For in vitr Terminated |
LCP | K070734 |
| Mar 23, 2006 | Alfa Wassermann, Inc Gemcal Reference Serum (magnesium calibrator). Calibrator, Multianalyte Mixture. Level 1 and Level 2 Chemistry Control. Terminated |
JIX | K930104 |