DART PHENOBARBITAL ASSAY SYSTEM— 510(k) K864612
Substantially EquivalentCoulter Electronics, Inc.
FDA 510(k) clearance K864612 for DART PHENOBARBITAL ASSAY SYSTEM, Substantially Equivalent on 1987-01-13. Applicant: Coulter Electronics, Inc.. Device class: 2.
Clearance details
- Applicant
- Coulter Electronics, Inc.
- Product code
- Code LFN
- Device class
- Class 2
- Regulation
- 21 CFR 862.3660
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hialeah, FL, US
Recent devices under product code LFN
view allMore clearances from Coulter Electronics, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.