Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DLB · Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
59 daysmedian FDA review time
91 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K961436 | ABUSCREEN ONLINE LSD REAGENT (90 ML TEST KIT) | Roche Diagnostic Systems, Inc. | 1996-06-21 | 67 | 0 |
| K955448 | EMIT II LSD ASSAY, EMIT LSD CALIBRATORS & EMIT LSD CONTROLS | Behring Diagnostics, Inc. | 1996-02-23 | 86 | 0 |
| K955814 | CEDIA DAU LSD ASSAY | Microgenics Corp. | 1996-02-09 | 45 | 0 |
| K954073 | STC DIAGNOSTICS LSD MICRO-PLATE EIA | Solarcare Technologies Corp,Inc. | 1995-11-29 | 91 | 0 |
| K891167 | COAT-A-COUNT(TM) LSD RADIOIMMUNOASSAY KIT | Diagnostic Products Corp. | 1989-05-03 | 58 | 0 |
| K874270 | REVISED LABELING FOR LSD TEST KIT | Roche Diagnostic Systems, Inc. | 1987-11-13 | 24 | 0 |
| K860525 | ABUSCREEN RADIOIMMUNOASSAY FOR LSD W/ REF STANDARD | Roche Diagnostic Systems, Inc. | 1986-04-11 | 59 | 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