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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name coulometric, chloride
510(K) Number K121823
Model 3400, SS-248
Device Name CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLORIDOMETER, CHLORIDE COULOMETRIC
Applicant
WESCOR, INC.
370 west 1700 south
logan,  UT  84321
Contact dawn t perdue
Regulation Number862.1170
Classification Product Code
JFS  
Subsequent Product Code
JJX  
Date Received06/21/2012
Decision Date 03/27/2013
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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