MINIQUANT D-DIMER, MODEL 1447— 510(k) K002642
Substantially EquivalentBiopool Intl., Inc.
FDA 510(k) clearance K002642 for MINIQUANT D-DIMER, MODEL 1447, Substantially Equivalent on 2001-02-05. Applicant: Biopool Intl., Inc..
Clearance details
- Applicant
- Biopool Intl., Inc.
- Product code
- Code DAP
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ventura, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.