Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Alfa Wassermann Diagnostic Technologies, LLC — Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K170623 | ACE Hemoglobin A1c (HbA1c) Reagent | Alfa Wassermann Diagnostic Technologies, LLC | 2018-02-27 | 363 | 0 |
| K131351 | ACE ALKALINE PHOSPHATASE REAGENT, AMYLASE REAGENT, ALT REAGE | Alfa Wassermann Diagnostic Technologies, LLC | 2013-08-15 | 97 | 1 |
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