Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Los Alamos Diagnostics — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
41 daysmedian FDA review time
109 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K896117 | MODIFIED MODEL 535(TM) LUMINOMETER | Los Alamos Diagnostics | 1989-11-30 | 41 | 0 |
| K883385 | RESUBMITTED UTISCREEN(TM) BACTERIAL ATP TEST | Los Alamos Diagnostics | 1988-09-07 | 29 | 0 |
| K882608 | LAD MODEL 633 LUMINOMETER | Los Alamos Diagnostics | 1988-08-29 | 66 | 0 |
| K881439 | MODIFIED UTISCREEN(TM) BACTERIAL ATP TEST SYSTEM | Los Alamos Diagnostics | 1988-04-28 | 23 | 0 |
| K874262 | LAD MODEL 735 LUMINOMETER | Los Alamos Diagnostics | 1987-11-27 | 38 | 0 |
| K864202 | UTISCREEN(R) BACTERIAL ATP TEST | Los Alamos Diagnostics | 1987-02-13 | 109 | 0 |
| K864201 | LAD MODEL 535 LUMINOMETER | Los Alamos Diagnostics | 1987-01-13 | 78 | 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