Alfa Wassermann Diagnostic Technologies, Inc.
West Caldwell, NJ, US
Alfa Wassermann Diagnostic Technologies, Inc. appears in FDA device records in West Caldwell, NJ. FDA records list 23 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 23
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 23 510(k) clearances for Alfa Wassermann Diagnostic Technologies, Inc. between 2008 and 2018. The busiest year on record is 2012, with 8. The most recent is 2018, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 7 |
| 2009 | 2 |
| 2011 | 1 |
| 2012 | 8 |
| 2013 | 4 |
| 2018 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K170623 | ACE Hemoglobin A1c (HbA1c) Reagent | LCP | Substantially Equivalent | |
| K131975 | ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENT | CFJ | Substantially Equivalent | |
| K131351 | ACE ALKALINE PHOSPHATASE REAGENT, AMYLASE REAGENT, ALT REAGENT, AST REAGENT | CJE | Substantially Equivalent | |
| K123953 | ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT | KHS | Substantially Equivalent | |
| K123018 | ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELECTRODE (ISE) MODULE | CFR | Substantially Equivalent | |
| K122757 | ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT | CHH | Substantially Equivalent | |
| K113389 | ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT | CDN | Substantially Equivalent | |
| K113437 | ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4 REAGENT, ACE FERRITIN REAGENT | LCP | Substantially Equivalent | |
| K113374 | ACE ALBUMIN REAGENT ACE TOTAL PROTEIN REAGENT ACE CALCIUM-ARSENAZO REAGENT ACE PHOSPHORUS U.V. REAGENT | CIX | Substantially Equivalent | |
| K113262 | ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT-C, ACE-TRISLYCERIDES REAGENT | CHH | Substantially Equivalent | |
| K113438 | ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, ACE LIPASE REAGENT | JMO | Substantially Equivalent | |
| K113253 | ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENT | JJE | Substantially Equivalent | |
| K112538 | ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT | CHH | Substantially Equivalent | |
| K103615 | ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANIC PHOSPHORUS U.V. REAGENT,URINE STANDARD | CDN | Substantially Equivalent | |
| K091711 | S- TEST HEMOGLOBIN ALC (HBA1C), MODEL RC0023 | LCP | Substantially Equivalent | |
| K083040 | S-TEST C-REACTIVE PROTEIN (CRP) | DCN | Substantially Equivalent | |
| K082226 | S40 CREATINE KINASE (CK) | JHS | Substantially Equivalent | |
| K072143 | S40 CLINICAL ANALYZER, S TEST ALB | CIX | Substantially Equivalent | |
| K073223 | S-TEST C02 | KHS | Substantially Equivalent | |
| K072142 | S40 CLINICAL ANALYZER, S TEST ALP, S TEST AMYLASE, S TEST AST | CKF | Substantially Equivalent | |
| K072356 | S-TEST CA | CJY | Substantially Equivalent | |
| K072141 | S40 CLINICAL ANALYZER, S TEST IP, S TEST UA | CEO | Substantially Equivalent | |
| K072140 | S40 CLINICAL ANALYZER, S TEST BIL, S TEST BUN, S TEST GLU | CFR | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- LCPAssay, Glycosylated Hemoglobin
- CJYAzo Dye, Calcium
- CIXBromcresol Green Dye-Binding, Albumin
- JHSDifferential Rate Kinetic Method, Cpk Or Isoenzymes
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- KHSEnzymatic, Carbon-Dioxide
- JMOFerrozine (Colorimetric) Iron Binding Capacity
- CFRHexokinase, Glucose
- CFJNad Reduction/Nadh Oxidation, Lactate Dehydrogenase
- CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- CKFPhenylphosphate, Alkaline Phosphatase Or Isoenzymes
- CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus
- DCNSystem, Test, C-Reactive Protein
- CDNUrease, Photometric, Urea Nitrogen
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain