COULTER GEN-S SYSTEM— 510(k) K962988

Substantially Equivalent

Coulter Corp.

FDA 510(k) clearance K962988 for COULTER GEN-S SYSTEM, Substantially Equivalent on 1996-10-30. Applicant: Coulter Corp..

Clearance details

Applicant: Coulter Corp.
Product code: Code GKL
Advisory panel: Hematology
Date received: 1996-08-01
Decision date: 1996-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

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