ELECTRA 800 AUTOMATIC COAGULATION TIMER— 510(k) K851169

Name: FDA 510(k) clearance K851169
Creator: U.S. Food and Drug Administration
Published: 1985-06-24

Substantially Equivalent

Medical Laboratory Automation Systems, Inc.

FDA 510(k) clearance K851169 for ELECTRA 800 AUTOMATIC COAGULATION TIMER, Substantially Equivalent on 1985-06-24. Applicant: Medical Laboratory Automation Systems, Inc.. Device class: 2.

Clearance details

Applicant: Medical Laboratory Automation Systems, Inc.
Product code: Code KQG
Device class: Class 2
Regulation: 21 CFR 864.5400
Advisory panel: Hematology
Date received: 1985-03-22
Decision date: 1985-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mount Vernon, NY, US

Download summary PDF View on FDA.gov ↗

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