Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lmd Laboratories — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
195 daysmedian FDA review time
266 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K955345 | LMD CRYPTOSPORIDIUM ANTIGEN DETECTION | Lmd Laboratories | 1996-06-07 | 199 | 0 |
| K942705 | E. COLI 0157 ELISA STOOL ASSAY | Lmd Laboratories | 1995-09-27 | 476 | 0 |
| K944871 | LMD GIARDIA ANTIGEN DETECTION ASSAY | Lmd Laboratories | 1995-06-22 | 262 | 0 |
| K905598 | CRYPTOSPORIDIUM ANTIGEN DETECTION | Lmd Laboratories | 1991-09-05 | 266 | 0 |
| K904613 | TRICHINELLA SEROLOGY MICROTITER ELISA | Lmd Laboratories | 1991-03-21 | 161 | 0 |
| K900780 | CYSTICERCOSIS SEROLOGICAL REAGENTS | Lmd Laboratories | 1990-10-04 | 226 | 0 |
| K890003 | GIARDIA STOOL ANTIGEN TEST KIT | Lmd Laboratories | 1989-03-14 | 70 | 0 |
| K883720 | TREND(R) EMERGE(TM) TOXOPLASMA IGG ELISA | Lmd Laboratories | 1989-01-24 | 146 | 0 |
| K870318 | AMEBIASIS ELISA TEST KIT | Lmd Laboratories | 1987-08-11 | 195 | 0 |
| K854230 | MEBIASIS AGAR GEL DIFFUSION KIT | Lmd Laboratories | 1985-11-12 | 22 | 0 |
| K854017 | ENTAMOEBA HISTOLYTICA-POSITIVE CONTROL(RABBIT) | Lmd Laboratories | 1985-10-22 | 22 | 0 |
| K844141 | ENTAMOEBA HISTOLYTICA HK-9 ANTIGEN (AXENIC) | Lmd Laboratories | 1984-12-06 | 44 | 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