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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 K884267
Device Name ELECTRODE A.PH BLOOD GAS B.ELECTROLYTE SYSTEMS
Applicant
Alko Diagnostic Corp.
Alko Park
333 Fiske St.
Holliston,  MA  01746
Applicant Contact ALEXANDER J KOVACS
Correspondent
Alko Diagnostic Corp.
Alko Park
333 Fiske St.
Holliston,  MA  01746
Correspondent Contact ALEXANDER J KOVACS
Regulation Number862.1120
Classification Product Code
CHL  
Date Received10/11/1988
Decision Date 05/04/1989
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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