TYTEM(R) REAGENT DISPENSER— 510(k) K871687

Name: FDA 510(k) clearance K871687
Creator: U.S. Food and Drug Administration
Published: 1987-05-20

Substantially Equivalent

Medical Laboratory Automation Systems, Inc.

FDA 510(k) clearance K871687 for TYTEM(R) REAGENT DISPENSER, Substantially Equivalent on 1987-05-20. Applicant: Medical Laboratory Automation Systems, Inc.. Device class: 1.

Clearance details

Applicant: Medical Laboratory Automation Systems, Inc.
Product code: Code JQW
Device class: Class 1
Regulation: 21 CFR 862.2750
Advisory panel: Clinical Chemistry
Date received: 1987-04-29
Decision date: 1987-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasantville, NY, US

Download summary PDF View on FDA.gov ↗

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