CELL-DYN 3000 CONTROL— 510(k) K902391

Substantially Equivalent

Unipath , Ltd.

FDA 510(k) clearance K902391 for CELL-DYN 3000 CONTROL, Substantially Equivalent on 1990-08-22. Applicant: Unipath , Ltd.. Device class: 2.

Clearance details

Applicant: Unipath , Ltd.
Product code: Code JCN
Device class: Class 2
Regulation: 21 CFR 864.8625
Advisory panel: Hematology
Date received: 1990-05-30
Decision date: 1990-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JCN

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K942209 — LIQUICHEK HEMATOLOGY-16 CONTROL, LOW, NORMAL AND HIGH1994-06-16
K934497 — CBC-STK(TM) HEMATOLOGY CONTROL/MULTIPLE1993-12-06
K911582 — STAK-CHEX1991-05-28
K902389 — TRI-COUNT 161990-08-22

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