Company ยท US
Alfa Wassermann Diagnostic Technologies, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2008 to 2018. Name variants (Inc, Corp, punctuation) are merged.
23510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 3 |
| LCP | Assay, Glycosylated Hemoglobin | 3 |
| CDN | Urease, Photometric, Urea Nitrogen | 2 |
| CFR | Hexokinase, Glucose | 2 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 2 |
| KHS | Enzymatic, Carbon-Dioxide | 2 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 1 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 1 |
| CJY | Azo Dye, Calcium | 1 |
| CKF | Phenylphosphate, Alkaline Phosphatase Or Isoenzymes | 1 |
| DCN | System, Test, C-Reactive Protein | 1 |
| JHS | Differential Rate Kinetic Method, Cpk Or Isoenzymes | 1 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 |
| JMO | Ferrozine (Colorimetric) Iron Binding Capacity | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 27, 2018 | K170623 | ACE Hemoglobin A1c (HbA1c) Reagent Alfa Wassermann Diagnostic Technologies, LLC | LCP |
| Oct 2, 2013 | K131975 | ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENT Alfa Wassermann Diagnostic Technologies, Inc. | CFJ |
| Aug 15, 2013 | K131351 | ACE ALKALINE PHOSPHATASE REAGENT, AMYLASE REAGENT, ALT REAGENT, AST REAGENT Alfa Wassermann Diagnostic Technologies, LLC | CJE |
| May 2, 2013 | K123953 | ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT Alfa Wassermann Diagnostic Technologies, Inc. | KHS |
| Apr 23, 2013 | K123018 | ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELECTRODE (ISE) MODULE Alfa Wassermann Diagnostic Technologies, Inc. | CFR |
| Oct 5, 2012 | K122757 | ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT Alfa Wassermann Diagnostic Technologies, Inc. | CHH |
| Aug 10, 2012 | K113389 | ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT Alfa Wassermann Diagnostic Technologies, Inc. | CDN |
| Aug 6, 2012 | K113437 | ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4 REAGENT, ACE FERRITIN REAGENT Alfa Wassermann Diagnostic Technologies, Inc. | LCP |
| Jul 13, 2012 | K113374 | ACE ALBUMIN REAGENT ACE TOTAL PROTEIN REAGENT ACE CALCIUM-ARSENAZO REAGENT ACE PHOSPHORUS U.V. REAGENT Alfa Wassermann Diagnostic Technologies, Inc. | CIX |
| Jul 3, 2012 | K113262 | ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT-C, ACE-TRISLYCERIDES REAGENT Alfa Wassermann Diagnostic Technologies, Inc. | CHH |
| Jun 1, 2012 | K113438 | ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, ACE LIPASE REAGENT Alfa Wassermann Diagnostic Technologies, Inc. | JMO |
| May 17, 2012 | K113253 | ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENT Alfa Wassermann Diagnostic Technologies, Inc. | JJE |
| Mar 29, 2012 | K112538 | ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT Alfa Wassermann Diagnostic Technologies, Inc. | CHH |
| Sep 8, 2011 | K103615 | ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANIC PHOSPHORUS U.V. REAGENT,URINE STANDARD Alfa Wassermann Diagnostic Technologies, Inc. | CDN |
| Dec 11, 2009 | K091711 | S- TEST HEMOGLOBIN ALC (HBA1C), MODEL RC0023 Alfa Wassermann Diagnostic Technologies, Inc. | LCP |
| Jan 30, 2009 | K083040 | S-TEST C-REACTIVE PROTEIN (CRP) Alfa Wassermann Diagnostic Technologies, Inc. | DCN |
| Sep 18, 2008 | K082226 | S40 CREATINE KINASE (CK) Alfa Wassermann Diagnostic Technologies, Inc. | JHS |
| Jul 14, 2008 | K072143 | S40 CLINICAL ANALYZER, S TEST ALB Alfa Wassermann Diagnostic Technologies, Inc. | CIX |
| Jun 26, 2008 | K073223 | S-TEST C02 Alfa Wassermann Diagnostic Technologies, Inc. | KHS |
| Jun 26, 2008 | K072142 | S40 CLINICAL ANALYZER, S TEST ALP, S TEST AMYLASE, S TEST AST Alfa Wassermann Diagnostic Technologies, Inc. | CKF |
| Jun 24, 2008 | K072356 | S-TEST CA Alfa Wassermann Diagnostic Technologies, Inc. | CJY |
| Jun 24, 2008 | K072141 | S40 CLINICAL ANALYZER, S TEST IP, S TEST UA Alfa Wassermann Diagnostic Technologies, Inc. | CEO |
| Jun 24, 2008 | K072140 | S40 CLINICAL ANALYZER, S TEST BIL, S TEST BUN, S TEST GLU Alfa Wassermann Diagnostic Technologies, Inc. | CFR |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||