Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Alfa Wassermann, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
166 daysmedian FDA review time
171 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K091413 | S-TEST CHOLESTEROL (CHO), MODEL RC0009, S-TEST HDL CHOLESTER | Alfa Wassermann, Inc. | 2009-10-26 | 166 | 0 |
| K091544 | S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017 | Alfa Wassermann, Inc. | 2009-09-09 | 105 | 0 |
| K091333 | S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022 | Alfa Wassermann, Inc. | 2009-08-03 | 89 | 0 |
| K080073 | S-TEST CREATININE (CRE) | Alfa Wassermann, Inc. | 2008-06-30 | 171 | 0 |
| K063306 | ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CAL | Alfa Wassermann, Inc. | 2007-04-17 | 167 | 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