HEMATOLOGY CALIBRATOR CONTROL— 510(k) K854166

Name: FDA 510(k) clearance K854166
Creator: U.S. Food and Drug Administration
Published: 1986-03-12

Substantially Equivalent

Interscience Diagnostics, Inc.

FDA 510(k) clearance K854166 for HEMATOLOGY CALIBRATOR CONTROL, Substantially Equivalent on 1986-03-12. Applicant: Interscience Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Interscience Diagnostics, Inc.
Product code: Code KRZ
Device class: Class 2
Regulation: 21 CFR 864.8165
Advisory panel: Hematology
Date received: 1985-10-15
Decision date: 1986-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fairview, OR, US

Download summary PDF View on FDA.gov ↗

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