DACOS PLUS LYTES OPTION— 510(k) K843239
Substantially EquivalentCoulter Electronics, Inc.
FDA 510(k) clearance K843239 for DACOS PLUS LYTES OPTION, Substantially Equivalent on 1984-10-17. Applicant: Coulter Electronics, Inc.. Device class: 2.
Clearance details
- Applicant
- Coulter Electronics, Inc.
- Product code
- Code CEM
- Device class
- Class 2
- Regulation
- 21 CFR 862.1600
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hialeah, FL, US
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