DART IRON & IRON BINDING CAPACITY REAGENT— 510(k) K854305
Substantially EquivalentCoulter Electronics, Inc.
FDA 510(k) clearance K854305 for DART IRON & IRON BINDING CAPACITY REAGENT, Substantially Equivalent on 1985-11-12. Applicant: Coulter Electronics, Inc.. Device class: 1.
Clearance details
- Applicant
- Coulter Electronics, Inc.
- Product code
- Code CFM
- Device class
- Class 1
- Regulation
- 21 CFR 862.1410
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hialeah, FL, US
Recent devices under product code CFM
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