HEPARIN ASSAY CARTRIDGES AND CONTROLS— 510(k) K944115

Name: FDA 510(k) clearance K944115
Creator: U.S. Food and Drug Administration
Published: 1995-03-24

Substantially Equivalent

Medtronic Hemotec, Inc.

FDA 510(k) clearance K944115 for HEPARIN ASSAY CARTRIDGES AND CONTROLS, Substantially Equivalent on 1995-03-24. Applicant: Medtronic Hemotec, Inc.. Device class: 2.

Clearance details

Applicant: Medtronic Hemotec, Inc.
Product code: Code GFT
Device class: Class 2
Regulation: 21 CFR 864.7525
Advisory panel: Hematology
Date received: 1994-08-23
Decision date: 1995-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Englewood, CO, US

Download summary PDF View on FDA.gov ↗

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