ISE CALIBRATOR FOR DUPONT DIMENSION— 510(k) K926518

Substantially Equivalent

Alko Diagnostic Corp.

FDA 510(k) clearance K926518 for ISE CALIBRATOR FOR DUPONT DIMENSION, Substantially Equivalent on 1993-01-28. Applicant: Alko Diagnostic Corp..

Clearance details

Applicant: Alko Diagnostic Corp.
Product code: Code JIX
Advisory panel: Clinical Chemistry
Date received: 1992-12-30
Decision date: 1993-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Holliston, MA, US

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