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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 K832779
Device Name REFEREE BLOOD GAS ANALYZER-ELECTRODES
Applicant
ANALYTICAL PRODUCTS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
ANALYTICAL PRODUCTS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1120
Classification Product Code
CHL  
Date Received08/16/1983
Decision Date 10/14/1983
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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