Alfa Wassermann, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Alfa Wassermann, Inc.” (first 2007, latest 2013), across 9 product codes in 2 review panels. Median 510(k) review time under this name: 167 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 3 | 234 |
| 2013 | 1 | 78 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 1 | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 | 1 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 1 | 1 |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 1 | 1 |
| JFY | Enzymatic Method, Creatinine | 1 | 1 |
| KHS | Enzymatic, Carbon-Dioxide | 1 | 1 |
| KLI | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | 1 | 1 |
| LCP | Assay, Glycosylated Hemoglobin | 1 | 1 |
| MRR | System, Test, Low Density, Lipoprotein | 1 | 1 |
Review panels
- Clinical Chemistry (8)
- Hematology (1)
Most recent Alfa Wassermann, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K131515 | ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT | KLI | 2013-08-14 | 78 |
| K113382 | ACE ALT REAGENT | CKA | 2012-07-19 | 246 |
| K113436 | ACE ALKALINE PHOSPHATASE REAGENT, ACE AMYLASE REAGENT, ACE LDH-L REAGENT | CJE | 2012-07-12 | 234 |
| K113435 | ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT | KHS | 2012-07-02 | 224 |
| K091413 | S-TEST CHOLESTEROL (CHO), MODEL RC0009, S-TEST HDL CHOLESTEROL (HDL), MODEL RC0015, S-TEST TRIGLYCERIDES (TG) | CHH | 2009-10-26 | 166 |
| K091544 | S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017 | CFJ | 2009-09-09 | 105 |
| K091333 | S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022 | MRR | 2009-08-03 | 89 |
| K080073 | S-TEST CREATININE (CRE) | JFY | 2008-06-30 | 171 |
| K063306 | ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72 | LCP | 2007-04-17 | 167 |
Recalls
5 product recalls in 4 recall events; 0 initiated in the last five years. Most recent: 2014-03-05.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Alfa Scientific Designs, Inc. (43 510(k)s)
- Alfa Wassermann Diagnostic Technologies, Inc. (23 510(k)s)
- Alfa Biotech (Uk) , Ltd. (3 510(k)s)
- Alfa Wassermann Diagnostics Technologies, LLC (3 510(k)s)
- Alfa Tech Medical Systems, Ltd. (2 510(k)s)
- Alfa Gate Mazen, Ltd. (1 510(k)s)
- Alfa Technologies, Inc. (1 510(k)s)
- Alfa Thermodiagnostics, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Alfa Wassermann, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Alfa Wassermann, Inc.” (first 2007, latest 2013), across 9 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Alfa Wassermann, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Alfa Wassermann, Inc. is 167 days.
Which FDA product codes appear under Alfa Wassermann, Inc.?
The most frequent FDA product codes under this applicant name are CFJ (Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase, 1); CHH (Enzymatic Esterase--Oxidase, Cholesterol, 1); CJE (Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes, 1).
Next steps
- See all 9 Alfa Wassermann, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CFJ, Alfa Wassermann, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.