ABCA-NT GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEM— 510(k) K974322

Name: FDA 510(k) clearance K974322
Creator: U.S. Food and Drug Administration
Published: 1997-12-16

Substantially Equivalent

Europa Scientific, Ltd.

FDA 510(k) clearance K974322 for ABCA-NT GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEM, Substantially Equivalent on 1997-12-16. Applicant: Europa Scientific, Ltd.. Device class: 1.

Clearance details

Applicant: Europa Scientific, Ltd.
Product code: Code DOP
Device class: Class 1
Regulation: 21 CFR 862.2860
Advisory panel: Clinical Chemistry
Date received: 1997-11-17
Decision date: 1997-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Concord, MA, US

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