Known Identifiers & Locations
FEI Numbers
N/A
Owner Operator Numbers
N/A
Locations Covered
N/A
Registered Establishments (0)
No device registration and listing records found for this entity.
510(k) Premarket Notifications (3)
| Submission # |
Device Name |
Decision Date |
Decision Description |
Action |
| DEN150057 |
Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5 |
2016-12-19 |
Unknown |
View Details
|
| K052101 |
C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C |
2005-08-26 |
Substantially Equivalent |
View Details
|
| K100538 |
TINA-QUANT FERRITIN GEN. 4 |
2010-06-22 |
Substantially Equivalent |
View Details
|
FDA Recall History (0)
No recall records found for this entity.
Profile Disclaimer
AvaSpecs compiles public data records from the FDA database. This compiled profile does not indicate endorsement, safety, clearance, approval, or compliance status. AvaSpecs is a private search index and is not affiliated with the FDA or any government agency.