DART THEOPHYLLINE REAGENT SYSTEM— 510(k) K870736
Substantially EquivalentCoulter Electronics, Inc.
FDA 510(k) clearance K870736 for DART THEOPHYLLINE REAGENT SYSTEM, Substantially Equivalent on 1987-04-14. Applicant: Coulter Electronics, Inc.. Device class: 2.
Clearance details
- Applicant
- Coulter Electronics, Inc.
- Product code
- Code KLS
- Device class
- Class 2
- Regulation
- 21 CFR 862.3880
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hialeah, FL, US
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