Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Chrono-Log Corp. — Predicate Candidate Screening
16 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
87 daysmedian FDA review time
233 days90th percentile
16clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K161329 | Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Plat | Chrono-Log Corp. | 2016-12-02 | 204 | 0 |
| K050265 | CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 700 | Chrono-Log Corp. | 2005-10-14 | 252 | 0 |
| K032951 | CHRONO-LOG WHOLE BLOOD AGGREGOMETER, MODELS 591A AND 592A | Chrono-Log Corp. | 2004-04-02 | 193 | 0 |
| K962426 | CHRONO-LOG WHOLE BLOOD AGGREGOMETER (WBA) 591/592 | Chrono-Log Corp. | 1996-10-22 | 120 | 0 |
| K945414 | RISTOCETIN COFACTOR ASSAY KIT | Chrono-Log Corp. | 1995-01-11 | 65 | 0 |
| K940792 | AGGRO/LINK VW COFACTOR SOFTWARE | Chrono-Log Corp. | 1994-10-13 | 233 | 0 |
| K932566 | AGGRO/LINK CONTROL SOFTWARE | Chrono-Log Corp. | 1993-11-02 | 159 | 0 |
| K922800 | PLATELET AGGREGATION REAGENTS | Chrono-Log Corp. | 1992-08-26 | 77 | 0 |
| K851025 | AGGRO/LINK COMPUTER INTERFACE | Chrono-Log Corp. | 1985-06-12 | 93 | 0 |
| K850592 | PLATELET AGGREGATION REAGENT | Chrono-Log Corp. | 1985-05-13 | 87 | 0 |
| K830749 | PLATELET AGGREGOMETER | Chrono-Log Corp. | 1983-05-16 | 68 | 0 |
| K820422 | PLATELET AGGREGOMETERS | Chrono-Log Corp. | 1982-03-16 | 28 | 0 |
| K781807 | REAGENT, FIREFLY #395 | Chrono-Log Corp. | 1978-11-22 | 28 | 0 |
| K771198 | LUMI-AGGREGOMETER | Chrono-Log Corp. | 1977-08-02 | 32 | 0 |
| K760159 | AGGREGOMETER, DUAL CHANNEL PLATELET | Chrono-Log Corp. | 1976-07-20 | 18 | 0 |
| K760198 | KIT, PLATELET AGGREGATION REAGENT (#390) | Chrono-Log Corp. | 1976-07-19 | 13 | 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