MANUAL BLOOD CELL COUNTING DEVICE— 510(k) K841026

Name: FDA 510(k) clearance K841026
Creator: U.S. Food and Drug Administration
Published: 1984-04-04

Substantially Equivalent

Instrumentation Laboratory CO

FDA 510(k) clearance K841026 for MANUAL BLOOD CELL COUNTING DEVICE, Substantially Equivalent on 1984-04-04. Applicant: Instrumentation Laboratory CO. Device class: 1.

Clearance details

Applicant: Instrumentation Laboratory CO
Product code: Code GKM
Device class: Class 1
Regulation: 21 CFR 864.6160
Advisory panel: Hematology
Date received: 1984-03-12
Decision date: 1984-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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