Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Alfa Wassermann Diagnostic Technologies, Inc. · Predicate Candidate Screening
21 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
224 daysmedian FDA review time
327 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K131975 | ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE T | Alfa Wassermann Diagnostic Technologies, Inc. | 2013-10-02 | 96 | 0 |
| K123953 | ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE | Alfa Wassermann Diagnostic Technologies, Inc. | 2013-05-02 | 132 | 0 |
| K123018 | ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, AC | Alfa Wassermann Diagnostic Technologies, Inc. | 2013-04-23 | 207 | 0 |
| K122757 | ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGEN | Alfa Wassermann Diagnostic Technologies, Inc. | 2012-10-05 | 28 | 0 |
| K113389 | ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,AC | Alfa Wassermann Diagnostic Technologies, Inc. | 2012-08-10 | 268 | 0 |
| K113437 | ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGEN | Alfa Wassermann Diagnostic Technologies, Inc. | 2012-08-06 | 259 | 0 |
| K113374 | ACE ALBUMIN REAGENT ACE TOTAL PROTEIN REAGENT ACE CALCIUM-AR | Alfa Wassermann Diagnostic Technologies, Inc. | 2012-07-13 | 240 | 0 |
| K113262 | ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGEN | Alfa Wassermann Diagnostic Technologies, Inc. | 2012-07-03 | 242 | 0 |
| K113438 | ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SE | Alfa Wassermann Diagnostic Technologies, Inc. | 2012-06-01 | 193 | 0 |
| K113253 | ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE | Alfa Wassermann Diagnostic Technologies, Inc. | 2012-05-17 | 197 | 0 |
| K112538 | ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGEN | Alfa Wassermann Diagnostic Technologies, Inc. | 2012-03-29 | 210 | 0 |
| K103615 | ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATINI | Alfa Wassermann Diagnostic Technologies, Inc. | 2011-09-08 | 273 | 1 |
| K091711 | S- TEST HEMOGLOBIN ALC (HBA1C), MODEL RC0023 | Alfa Wassermann Diagnostic Technologies, Inc. | 2009-12-11 | 184 | 0 |
| K083040 | S-TEST C-REACTIVE PROTEIN (CRP) | Alfa Wassermann Diagnostic Technologies, Inc. | 2009-01-30 | 108 | 0 |
| K082226 | S40 CREATINE KINASE (CK) | Alfa Wassermann Diagnostic Technologies, Inc. | 2008-09-18 | 42 | 0 |
| K072143 | S40 CLINICAL ANALYZER, S TEST ALB | Alfa Wassermann Diagnostic Technologies, Inc. | 2008-07-14 | 347 | 0 |
| K073223 | S-TEST C02 | Alfa Wassermann Diagnostic Technologies, Inc. | 2008-06-26 | 224 | 0 |
| K072142 | S40 CLINICAL ANALYZER, S TEST ALP, S TEST AMYLASE, S TEST AS | Alfa Wassermann Diagnostic Technologies, Inc. | 2008-06-26 | 329 | 0 |
| K072356 | S-TEST CA | Alfa Wassermann Diagnostic Technologies, Inc. | 2008-06-24 | 307 | 0 |
| K072140 | S40 CLINICAL ANALYZER, S TEST BIL, S TEST BUN, S TEST GLU | Alfa Wassermann Diagnostic Technologies, Inc. | 2008-06-24 | 327 | 0 |
| K072141 | S40 CLINICAL ANALYZER, S TEST IP, S TEST UA | Alfa Wassermann Diagnostic Technologies, Inc. | 2008-06-24 | 327 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda