CELLECT 8E AUTOMATED BLOOD CELL COUNTERS— 510(k) K862374

Name: FDA 510(k) clearance K862374
Creator: U.S. Food and Drug Administration
Published: 1986-09-04

Substantially Equivalent

Instrumentation Laboratory CO

FDA 510(k) clearance K862374 for CELLECT 8E AUTOMATED BLOOD CELL COUNTERS, Substantially Equivalent on 1986-09-04. Applicant: Instrumentation Laboratory CO. Device class: 2.

Clearance details

Applicant: Instrumentation Laboratory CO
Product code: Code GKL
Device class: Class 2
Regulation: 21 CFR 864.5200
Advisory panel: Hematology
Date received: 1986-06-24
Decision date: 1986-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lexington, MA, US

Download summary PDF View on FDA.gov ↗

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