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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
510(k) Number K873577
Device Name GEM-STAT, GEM-PAK 2, GEM-CHECK, GEM-CRIT CHECK
Applicant
Diamond Sensor Systems
1230 Eisenhower Pl.
Ann Arbor,  MI  48104
Applicant Contact ENZER, PH.D.
Correspondent
Diamond Sensor Systems
1230 Eisenhower Pl.
Ann Arbor,  MI  48104
Correspondent Contact ENZER, PH.D.
Regulation Number862.1120
Classification Product Code
CHL  
Date Received09/03/1987
Decision Date 04/28/1988
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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