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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name analyzer, chemistry (photometric, discrete), for clinical use
510(k) Number K832584
Device Name TUBING KIT 446
Original Applicant
Regulation Number862.2160
Classification Product Code
Date Received08/02/1983
Decision Date 09/12/1983
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No