Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Labsystems, Inc. — Predicate Candidate Screening
17 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
43 daysmedian FDA review time
285 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K923365 | TILT/REDUCED SHEAR SEMI-RECLINE SEATING SYSTEM | Labsystems, Inc. | 1993-03-24 | 259 | 0 |
| K896474 | RESUBMITTED FECATWIN SENSITIVE - FECA-EIA | Labsystems, Inc. | 1990-01-25 | 73 | 0 |
| K890154 | MODIFIED LABYSYSTEMS' TOXOPLASMA GONDII IGG EIA | Labsystems, Inc. | 1989-02-07 | 26 | 0 |
| K890091 | MODIFIED LABSYSTEMS' RUBELLA IGG EIA TEST KIT | Labsystems, Inc. | 1989-02-03 | 29 | 0 |
| K881243 | RUBELLA IGG - EIA TEST KIT NUMBER 61 07 201 | Labsystems, Inc. | 1988-04-04 | 14 | 0 |
| K873780 | MODIFICATION RUBELLA IGM EIA TEST KIT | Labsystems, Inc. | 1987-10-15 | 35 | 0 |
| K873583 | AUTO-EIA | Labsystems, Inc. | 1987-09-22 | 19 | 0 |
| K872252 | MODIFIED TOXOPLASMA GONDII IGG EIA TEST KIT | Labsystems, Inc. | 1987-07-01 | 20 | 0 |
| K862705 | CYTOMEGALOVIRUS IGG EIA TEST KIT | Labsystems, Inc. | 1986-10-01 | 77 | 0 |
| K862431 | RUBELLA IGM EIA TEST KIT | Labsystems, Inc. | 1986-08-08 | 43 | 0 |
| K862216 | TOXOPLASMA GONDII IGG EIA TEST KIT (AMENDMENT) | Labsystems, Inc. | 1986-06-30 | 20 | 0 |
| K853696 | RUBELLA IGG EIA TEST KIT | Labsystems, Inc. | 1986-06-17 | 285 | 0 |
| K843189 | CYTOMEGALOVIRUS IGG EIA TEST KIT | Labsystems, Inc. | 1986-01-08 | 513 | 0 |
| K842797 | TOXOPLASMA GONDII IGM EIA TEST KIT | Labsystems, Inc. | 1984-10-17 | 92 | 0 |
| K842773 | LABSYSTEMS FP-901 CHEMISTRY ANALYZER | Labsystems, Inc. | 1984-09-04 | 50 | 0 |
| K833829 | TOXOPLASMA GOND II IGG DIA TEST KIT | Labsystems, Inc. | 1984-04-24 | 173 | 0 |
| K841214 | LABSYSTEMS UNISKAN | Labsystems, Inc. | 1984-04-13 | 22 | 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