THERMO DMA FRUCTOSAMINE ASSAY, MODEL 7500-135/235— 510(k) K012525

Name: FDA 510(k) clearance K012525
Creator: U.S. Food and Drug Administration
Published: 2001-10-04

Substantially Equivalent

Thermo Dma, Inc.

FDA 510(k) clearance K012525 for THERMO DMA FRUCTOSAMINE ASSAY, MODEL 7500-135/235, Substantially Equivalent on 2001-10-04. Applicant: Thermo Dma, Inc.. Device class: 2.

Clearance details

Applicant: Thermo Dma, Inc.
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 2001-08-06
Decision date: 2001-10-04
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Arlington, TX, US

Download summary PDF View on FDA.gov ↗

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