Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Laboratory Products, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
41 daysmedian FDA review time
53 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K832588 | CIN AGAR | Laboratory Products, Inc. | 1983-09-12 | 41 | 0 |
| K803051 | FLAME PHOTOMETRY REAGENTS | Laboratory Products, Inc. | 1981-01-09 | 38 | 0 |
| K803013 | CHLORIDE/TCO2 ANALYZER REAGENTS | Laboratory Products, Inc. | 1981-01-02 | 35 | 0 |
| K803050 | SPRAY, SYNTHETIC SMEAR | Laboratory Products, Inc. | 1980-12-30 | 28 | 0 |
| K800180 | VARIOUS REAGENTS FOR BLOOD CELL ANALYZER | Laboratory Products, Inc. | 1980-03-19 | 50 | 0 |
| K792482 | CHEMISTRY ANALYZER REAGENTS | Laboratory Products, Inc. | 1980-01-11 | 53 | 0 |
| K792481 | CULTURE PLATES & TUBED MEDIA | Laboratory Products, Inc. | 1979-12-31 | 42 | 0 |
| K792483 | STAINS, COUNTERSTAINS & GEN. PURPOSE | Laboratory Products, Inc. | 1979-12-18 | 29 | 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