Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Logos Scientific, Inc. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
35 daysmedian FDA review time
265 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K902614 | ELVI 828 DIGICLOT MULTISCAN | Logos Scientific, Inc. | 1990-11-08 | 148 | 0 |
| K843375 | ELVI 655 FLAME PHOTOMETER | Logos Scientific, Inc. | 1985-05-20 | 265 | 0 |
| K844710 | EUROCHIMA SERUM PROTEIN ELECTROPHORESIS METHOD | Logos Scientific, Inc. | 1985-01-07 | 35 | 0 |
| K843296 | ELVI 675 DIGITRON | Logos Scientific, Inc. | 1984-09-13 | 23 | 0 |
| K842313 | ELVI 146 SEROSCAN | Logos Scientific, Inc. | 1984-09-10 | 90 | 0 |
| K842056 | ELVI 165 PROTEO SEROSKOP | Logos Scientific, Inc. | 1984-06-22 | 31 | 0 |
| K841804 | ELVI 70 SAFETY CHAMBER | Logos Scientific, Inc. | 1984-05-31 | 30 | 0 |
| K840757 | ELVI 444 BILITRON | Logos Scientific, Inc. | 1984-05-30 | 97 | 0 |
| K841288 | ELVI 18 | Logos Scientific, Inc. | 1984-05-02 | 35 | 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