DART IMMUNOGLOBULINS REAGENT SYSTEM— 510(k) K851541

Substantially Equivalent

Coulter Electronics, Inc.

FDA 510(k) clearance K851541 for DART IMMUNOGLOBULINS REAGENT SYSTEM, Substantially Equivalent on 1985-07-15. Applicant: Coulter Electronics, Inc..

Clearance details

Applicant: Coulter Electronics, Inc.
Product code: Code DEW
Advisory panel: Immunology
Date received: 1985-04-16
Decision date: 1985-07-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hialeah, FL, US

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