Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LGP · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
82 daysmedian FDA review time
97 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K864213 | IL TEST 97572-15, ALPHA 2-ANTIPLASMIN ASSAY | Instrumentation Laboratory CO | 1986-11-25 | 28 | 0 |
| K850411 | GEN. DIAG. CHROMOSTRATE ALPHA-2 ANTIPLASMIN ASSAY | Warner-Lambert Co. | 1985-05-08 | 93 | 0 |
| K833890 | COATEST ANTIPLASMIN | Kabivitrum, Inc. | 1984-01-30 | 82 | 0 |
| K802840 | ALPHA-ANTIPLASM ASSAY | American Dade | 1981-02-17 | 97 | 0 |
| K803110 | PROTEOLYTIC ENZYME CONTROL | American Dade | 1981-02-17 | 69 | 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