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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
510(k) Number K882450
Device Name GEM-STAT W/COMP. GEM-STATPAK/GEM-CHECK & CRIT CHK.
Applicant
Diamond Sensor Systems
1230 Eisenhower Pl.
Ann Arbor,  MI  48104
Applicant Contact ENZER, PHD
Correspondent
Diamond Sensor Systems
1230 Eisenhower Pl.
Ann Arbor,  MI  48104
Correspondent Contact ENZER, PHD
Regulation Number862.2160
Classification Product Code
JJE  
Date Received06/14/1988
Decision Date 07/28/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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