Data / Medical devices / United States / Chrono-Log Corp.
Chrono-Log Corp.: FDA-registered device maker in Havertown, PA, United States, 8 510(k) clearances
Chrono-Log Corp. is registered with the FDA (registration 2518152) in Havertown, PA, United States. It lists 4 device types. The FDA files 8 510(k) clearances under its listings, the newest dated December 2, 2016. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2518152
- Address
- 2 West Park RD., Havertown, PA, United States, 19083
- Owner or operator
- CHRONO-LOG CORP. (2518152)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- May 13, 1996
- Registered through
- 2027
- Brand names listed
- AGGRO/LINK Control Software, AGGRO/LINK vW CoFactor Software, Arachidonic Acid, CHRONO-LUME, Chrono-Par Kit P/N 380, Chrono-log Platelet Aggregometer, 4 channel Model 490 4+, Chrono-log Platelet Aggregometer, 8 channel Model 490 4+4, Platelet Aggregation Reagents and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Aggregrometer, Platelet | JBX | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Reagent, Platelet Aggregation | GHR | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| System, Automated Platelet Aggregation | JOZ | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Test, Qualitative And Quantitative Factor Deficiency | GGP | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 2, 2016 | K161329 | Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channel | JOZ | Substantially Equivalent | Chrono-Log Corp. | accessdata.fda.gov |
| October 14, 2005 | K050265 | CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 700 | JOZ | Substantially Equivalent | Chrono-Log Corp. | accessdata.fda.gov |
| January 11, 1995 | K945414 | RISTOCETIN COFACTOR ASSAY KIT | GGP | Substantially Equivalent | Chrono-Log Corp. | accessdata.fda.gov |
| October 13, 1994 | K940792 | AGGRO/LINK VW COFACTOR SOFTWARE | JOZ | Substantially Equivalent | Chrono-Log Corp. | accessdata.fda.gov |
| November 2, 1993 | K932566 | AGGRO/LINK CONTROL SOFTWARE | JBX | Substantially Equivalent | Chrono-Log Corp. | accessdata.fda.gov |
| August 26, 1992 | K922800 | PLATELET AGGREGATION REAGENTS | GHR | Substantially Equivalent | Chrono-Log Corp. | accessdata.fda.gov |
| May 13, 1985 | K850592 | PLATELET AGGREGATION REAGENT | JBX | Substantially Equivalent | Chrono-Log Corp. | accessdata.fda.gov |
| November 22, 1978 | K781807 | REAGENT, FIREFLY #395 | JOZ | Substantially Equivalent | Chrono-Log Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Aggregrometer, Platelet
- All makers of System, Automated Platelet Aggregation
- All makers of Test, Qualitative And Quantitative Factor Deficiency
- All makers of Reagent, Platelet Aggregation
Updated December 2, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.