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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name mass spectrometer, clinical use
510(k) Number K992163
Device Name ABCA GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEMS
Applicant
PDZ-EUROPA LTD.
325COLLEGE RD.
CONCORD,  MA  01742
Applicant Contact ROBERT F MARTIN
Correspondent
PDZ-EUROPA LTD.
325COLLEGE RD.
CONCORD,  MA  01742
Correspondent Contact ROBERT F MARTIN
Regulation Number862.2860
Classification Product Code
DOP  
Date Received06/25/1999
Decision Date 07/13/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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