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..
Clearance details
- Applicant
- Coulter Electronics, Inc.
- Product code
- Code LFN
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hialeah, FL, US
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