GRANULOCOLOR— 510(k) K860320

Substantially Equivalent

Cytocolor, Inc.

FDA 510(k) clearance K860320 for GRANULOCOLOR, Substantially Equivalent on 1986-02-20. Applicant: Cytocolor, Inc.. Device class: 1.

Clearance details

Applicant: Cytocolor, Inc.
Product code: Code LED
Device class: Class 1
Regulation: 21 CFR 864.1850
Advisory panel: Hematology
Date received: 1986-01-28
Decision date: 1986-02-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hinckley, OH, US

Download summary PDF View on FDA.gov ↗

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More clearances from Cytocolor, Inc.

K860319 — MEGACOLOR1986-02-20
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Data sourced from openFDA. This site is unofficial and independent of the FDA.