510(k) K853239— HEPTEST-A QUANTITATIVE HEPARIN IN PLASMA ASSAY
Substantially EquivalentHaemachem, Inc.
Clearance details
- Applicant
- Haemachem, Inc.
- Product code
- Code KFF
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Louis, MO, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.