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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 K760748
Device Name REAGENTS FOR BLOOD GAS INSTRUMENTATION
Applicant
Alko Scientific Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Alko Scientific Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1120
Classification Product Code
CHL  
Date Received08/27/1976
Decision Date 11/01/1976
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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