FDA Registration
Active
🇺🇸 United States
CHRONO-LOG CORP.
Reg #: 2518152
·
FEI: 2518152
·
Expires 2026
Products
4
Proprietary Names
11
Establishment Types
3
Classifications
4
Registration Details
- Registration Name
- CHRONO-LOG CORP.
- Registration Number
- 2518152
- FEI Number
- 2518152
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2 WEST PARK RD.
- City
- HAVERTOWN
- State
- PA
- ZIP
- 19083
- Country
- US
Regulatory Submissions
- 510(k) Number
- K161329
Owner / Operator
- Firm Name
- CHRONO-LOG CORP.
- Operator Number
- 2518152
- Address
- 2 WEST PARK RD., --
- City
- Havertown
- State
- PA
- Postal Code
- 19083
- Country
- US
- Correspondent
- Gemal Mahmud
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Automated Platelet Aggregation | JOZ | Class 2 | Hematology | No | 2016-12-27 |
| Reagent, Platelet Aggregation | GHR | Class 2 | Hematology | No | 2007-11-01 |
| Aggregrometer, Platelet | JBX | Class 2 | Hematology | No | 2016-01-13 |
| Test, Qualitative And Quantitative Factor Deficiency | GGP | Class 2 | Hematology | No | 2007-11-01 |
Proprietary Names
Chrono-log Platelet Aggregometer, 4 channel Model 490 4+
Chrono-log Platelet Aggregometer, 8 channel Model 490 4+4
Chrono-Par Kit P/N 380
Platelet Aggregation Reagents
Arachidonic Acid
AGGRO/LINK Control Software
CHRONO-LUME
Whole Blood Aggregometer
WHOLE BLOOD LUMI-AGGREGOMETER
AGGRO/LINK vW CoFactor Software
Ristocetin Cofactor Assay P/N 299
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility