Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Allergenetics — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
48 daysmedian FDA review time
161 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K851512 | ALLERGENETICS IGE FAST TEST | Allergenetics | 1985-05-28 | 43 | 0 |
| K842970 | ALLERGENTICS TOTAL IGE/THEOPHYLLINE | Allergenetics | 1984-08-29 | 30 | 0 |
| K842969 | ALLERGENETICS ALLER-SPECIFIC IGE SERUM | Allergenetics | 1984-08-28 | 29 | 0 |
| K833418 | CHYMOFAST TEST | Allergenetics | 1984-03-12 | 161 | 0 |
| K834594 | TOTAL IGE FAST TEST | Allergenetics | 1984-02-10 | 43 | 0 |
| K833419 | LABELED 125I ANTI-IGE | Allergenetics | 1984-02-03 | 123 | 0 |
| K834244 | THEOFAST TEST KIT FOR QUANTITATIVE THEO | Allergenetics | 1984-01-24 | 48 | 0 |
| K822341 | ALLERGENETICS IGE-FAST TEST | Allergenetics | 1982-11-10 | 98 | 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