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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
SHABAN MFG. CO.
Regulation Number862.2160
Classification Product Code
JJE  
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
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