Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GHD · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K904022 | NITRO BLUE TETRAZOLIUM REDUCTION | Sigma Chemical Co. | 1990-12-18 | 110 | 0 |
| K903995 | NAPHTHOL AS-D CHLOR/A-NAPHTHYL ACET ESTERASE KIT | Sigma Chemical Co. | 1990-12-13 | 106 | 0 |
| K896092 | ALKALINE PHOSPHATASE, LEUKOCYTE, KIT | Sigma Chemical Co. | 1989-11-09 | 21 | 0 |
| K811189 | CHEMSTRIP L | Biodynamics Corp. | 1981-07-27 | 89 | 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