ABCA GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEMS— 510(k) K992163

Name: FDA 510(k) clearance K992163
Creator: U.S. Food and Drug Administration
Published: 1999-07-13

Substantially Equivalent

Pdz-Europa , Ltd.

FDA 510(k) clearance K992163 for ABCA GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEMS, Substantially Equivalent on 1999-07-13. Applicant: Pdz-Europa , Ltd.. Device class: 1.

Clearance details

Applicant: Pdz-Europa , Ltd.
Product code: Code DOP
Device class: Class 1
Regulation: 21 CFR 862.2860
Advisory panel: Clinical Chemistry
Date received: 1999-06-25
Decision date: 1999-07-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Concord, MA, US

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