THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609— 510(k) K012878

Name: FDA 510(k) clearance K012878
Creator: U.S. Food and Drug Administration
Published: 2001-10-16

Substantially Equivalent

Thermo Dma, Inc.

FDA 510(k) clearance K012878 for THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609, Substantially Equivalent on 2001-10-16. Applicant: Thermo Dma, Inc.. Device class: 2.

Clearance details

Applicant: Thermo Dma, Inc.
Product code: Code JIS
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 2001-08-28
Decision date: 2001-10-16
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Arlington, TX, US

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