Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JZQ — Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
28 daysmedian FDA review time
82 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K881174 | RID PLATE READER | The Binding Site, Ltd. | 1988-06-08 | 82 | 0 |
| K881675 | IMMULON 4 FLAT BOTTOM PLATES & REMOVAWELL STRIPS | Dynatech Laboratories, Inc. | 1988-04-21 | 3 | 0 |
| K831811 | REVOLUTION RADIAL IMMUNODIFFUSION PLATE | Calbiochem-Behring Corp. | 1983-07-28 | 52 | 0 |
| K792699 | OUCHTERLONY AGAR PLATES | Meridian Diagnostics, Inc. | 1980-01-24 | 28 | 0 |
| K790646 | HELENA QUIPLATE SYSTEM | Helena Laboratories | 1979-05-23 | 54 | 0 |
| K770548 | IMMUNOPLATE III RADIO IMMUNODIFFUSION | Hyland Therapeutic Div., Travenol Laboratories | 1977-04-15 | 25 | 0 |
| K761311 | ACCRAASSAY RID KITS | Miles Laboratories, Inc. | 1976-12-30 | 7 | 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