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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
Predetermined Change
Control Plan Authorized		 No
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