510(k) K965113— N-ASSAY TIA FIBRINOGEN TEST KIT
Substantially EquivalentCrestat Diagnostics, Inc.
Clearance details
- Applicant
- Crestat Diagnostics, Inc.
- Product code
- Code KQJ
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Weston, CT, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.