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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 K832003
Device Name AQUEOUS BLOOD GAS CONTROL LEVEL I,II &
Original Applicant
AMERICAN DADE
Regulation Number862.1660
Classification Product Code
JJS  
Date Received06/22/1983
Decision Date 08/10/1983
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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