DART IMMUNOGLOBULINS REAGENT SYSTEM— 510(k) K851541
Substantially EquivalentCoulter Electronics, Inc.
FDA 510(k) clearance K851541 for DART IMMUNOGLOBULINS REAGENT SYSTEM, Substantially Equivalent on 1985-07-15. Applicant: Coulter Electronics, Inc.. Device class: 2.
Clearance details
- Applicant
- Coulter Electronics, Inc.
- Product code
- Code DEW
- Device class
- Class 2
- Regulation
- 21 CFR 866.5510
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hialeah, FL, US
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