CELL-DYN CALIBRATOR— 510(k) K902892

Substantially Equivalent

Unipath , Ltd.

FDA 510(k) clearance K902892 for CELL-DYN CALIBRATOR, Substantially Equivalent on 1990-09-10. Applicant: Unipath , Ltd.. Device class: 2.

Clearance details

Applicant: Unipath , Ltd.
Product code: Code KRZ
Device class: Class 2
Regulation: 21 CFR 864.8165
Advisory panel: Hematology
Date received: 1990-07-02
Decision date: 1990-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.