DART AMYLASE-D.S. REAGENT SYSTEM— 510(k) K862370
Substantially EquivalentCoulter Electronics, Inc.
FDA 510(k) clearance K862370 for DART AMYLASE-D.S. REAGENT SYSTEM, Substantially Equivalent on 1986-08-01. Applicant: Coulter Electronics, Inc..
Clearance details
- Applicant
- Coulter Electronics, Inc.
- Product code
- Code CIJ
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hialeah, FL, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.