COULTER ACT TRON CELL CONTROL— 510(k) K971469

Substantially Equivalent

Coulter Corp.

FDA 510(k) clearance K971469 for COULTER ACT TRON CELL CONTROL, Substantially Equivalent on 1997-06-30. Applicant: Coulter Corp..

Clearance details

Applicant: Coulter Corp.
Product code: Code JPK
Advisory panel: Hematology
Date received: 1997-04-22
Decision date: 1997-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

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