Alfa Wassermann Diagnostic Technologies, Inc.: FDA clearances and approvals
Alfa Wassermann Diagnostic Technologies, Inc. has 23 FDA 510(k) clearances (first 2008, latest 2018), across 15 product codes in 3 review panels. Median 510(k) review time: 224 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 8 | 225 |
| 2013 | 4 | 114 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 363 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Alfa Wassermann Diagnostic Technologies, Inc.'s cleared 510(k)s took a median 363 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 226 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 3 | 3 |
| LCP | Assay, Glycosylated Hemoglobin | 3 | 3 |
| CDN | Urease, Photometric, Urea Nitrogen | 2 | 2 |
| CFR | Hexokinase, Glucose | 2 | 2 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 2 | 2 |
| KHS | Enzymatic, Carbon-Dioxide | 2 | 2 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 | 1 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 1 | 1 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 1 | 1 |
| CJY | Azo Dye, Calcium | 1 | 1 |
Plus 5 more product codes.
Review panels
- Clinical Chemistry (19)
- Hematology (3)
- Immunology (1)
Most recent Alfa Wassermann Diagnostic Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K170623 | ACE Hemoglobin A1c (HbA1c) Reagent | LCP | 2018-02-27 | 363 |
| K131975 | ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENT | CFJ | 2013-10-02 | 96 |
| K131351 | ACE ALKALINE PHOSPHATASE REAGENT, AMYLASE REAGENT, ALT REAGENT, AST REAGENT | CJE | 2013-08-15 | 97 |
| K123953 | ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT | KHS | 2013-05-02 | 132 |
| K123018 | ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELECTRODE (ISE) MODULE | CFR | 2013-04-23 | 207 |
| K122757 | ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT | CHH | 2012-10-05 | 28 |
| K113389 | ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT | CDN | 2012-08-10 | 268 |
| K113437 | ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4 REAGENT, ACE FERRITIN REAGENT | LCP | 2012-08-06 | 259 |
| K113374 | ACE ALBUMIN REAGENT ACE TOTAL PROTEIN REAGENT ACE CALCIUM-ARSENAZO REAGENT ACE PHOSPHORUS U.V. REAGENT | CIX | 2012-07-13 | 240 |
| K113262 | ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT-C, ACE-TRISLYCERIDES REAGENT | CHH | 2012-07-03 | 242 |
13 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Alfa Wassermann Diagnostic Technologies, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Alfa Wassermann Diagnostic Technologies, Inc. have?
Alfa Wassermann Diagnostic Technologies, Inc. has 23 FDA 510(k) clearances (first 2008, latest 2018), across 15 product codes in 3 review panels.
How long does FDA take to clear Alfa Wassermann Diagnostic Technologies, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Alfa Wassermann Diagnostic Technologies, Inc.'s cleared 510(k)s is 224 days.
What devices does Alfa Wassermann Diagnostic Technologies, Inc. make?
Its most frequent FDA product codes are CHH (Enzymatic Esterase--Oxidase, Cholesterol, 3); LCP (Assay, Glycosylated Hemoglobin, 3); CDN (Urease, Photometric, Urea Nitrogen, 2).
Has Alfa Wassermann Diagnostic Technologies, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Alfa Wassermann Diagnostic Technologies, Inc. Related entities may recall under other names.
Next steps
- See all 23 Alfa Wassermann Diagnostic Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CHH, Alfa Wassermann Diagnostic Technologies, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.