Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KQP — Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
219 daysmedian FDA review time
322 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K102643 | SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT | Astoria-Pacific, Inc. | 2011-07-15 | 304 | 0 |
| K101392 | NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL N | Astoria-Pacific, Inc. | 2011-02-04 | 262 | 0 |
| K100101 | GSP NEONATALGALT KIT, MODEL 3303-001U | Perkinelmer, Inc. | 2010-06-11 | 149 | 1 |
| K993536 | BIO-RAD CODA NEONATAL GALT ASSAY | Bio-Rad | 1999-11-04 | 16 | 0 |
| K990827 | MICROPLATE NEONATAL GALT ASSAY | Bio-Rad | 1999-04-09 | 28 | 0 |
| K970277 | URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K) | Astoria-Pacific, Inc. | 1997-12-11 | 322 | 1 |
| K894011 | TOTAL GALACTOSE | Alpkem Corp. | 1990-01-11 | 219 | 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