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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Controls For Blood-Gases, (Assayed And Unassayed)
510(k) Number K770228
Device Name AQUEOUS PH/BLOOD GAS CONTROLS
Applicant
Instrumentation Laboratory CO
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Instrumentation Laboratory CO
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1660
Classification Product Code
JJS  
Date Received02/07/1977
Decision Date 06/27/1977
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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