Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
P-L Biochemicals, Inc. · Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K813449 | PHE/TYR KINETIC UV TEST SET | P-L Biochemicals, Inc. | 1981-12-31 | 21 | 0 |
| K800517 | TOBRAM E.R.A. TM | P-L Biochemicals, Inc. | 1980-03-20 | 15 | 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