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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ph Rate Measurement, Carbon-Dioxide
510(k) Number K800586
Device Name NSI CARBON DIOXIDE REAGENT KIT
Applicant
Nobel Scientific Industries, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Nobel Scientific Industries, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1160
Classification Product Code
JFL  
Date Received03/17/1980
Decision Date 04/04/1980
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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