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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
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