Chrono-Log Corp.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Chrono-Log Corp.” (first 1976, latest 2016), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 82 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 204 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JOZ | System, Automated Platelet Aggregation | 6 | 6 |
| JBX | Aggregrometer, Platelet | 5 | 5 |
| GHR | Reagent, Platelet Aggregation | 3 | 3 |
| GGP | Test, Qualitative And Quantitative Factor Deficiency | 1 | 1 |
| JBY | Aggregometer, Platelet, Photo-Optical Scanning | 1 | 1 |
Review panels
- Hematology (16)
Most recent Chrono-Log Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K161329 | Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channel | JOZ | 2016-12-02 | 204 |
| K050265 | CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 700 | JOZ | 2005-10-14 | 252 |
| K032951 | CHRONO-LOG WHOLE BLOOD AGGREGOMETER, MODELS 591A AND 592A | JOZ | 2004-04-02 | 193 |
| K962426 | CHRONO-LOG WHOLE BLOOD AGGREGOMETER (WBA) 591/592 | JOZ | 1996-10-22 | 120 |
| K945414 | RISTOCETIN COFACTOR ASSAY KIT | GGP | 1995-01-11 | 65 |
| K940792 | AGGRO/LINK VW COFACTOR SOFTWARE | JOZ | 1994-10-13 | 233 |
| K932566 | AGGRO/LINK CONTROL SOFTWARE | JBX | 1993-11-02 | 159 |
| K922800 | PLATELET AGGREGATION REAGENTS | GHR | 1992-08-26 | 77 |
| K851025 | AGGRO/LINK COMPUTER INTERFACE | JBX | 1985-06-12 | 93 |
| K850592 | PLATELET AGGREGATION REAGENT | JBX | 1985-05-13 | 87 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Chrono-Log Corp..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Chrono-Log Corp.?
FDA lists 16 510(k) clearances under the applicant name “Chrono-Log Corp.” (first 1976, latest 2016), across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Chrono-Log Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Chrono-Log Corp. is 82 days.
Which FDA product codes appear under Chrono-Log Corp.?
The most frequent FDA product codes under this applicant name are JOZ (System, Automated Platelet Aggregation, 6); JBX (Aggregrometer, Platelet, 5); GHR (Reagent, Platelet Aggregation, 3).
Next steps
- See all 16 Chrono-Log Corp. clearances with predicates and recalls
- Run predicate analysis for product code JOZ, Chrono-Log Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.