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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 K183375
Device Name Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode
Applicant
Horiba, Ltd
2 Miyanohigashi, Kisshoin, Minami-ku
Kyoto,  JP 601-8510
Applicant Contact Naoyuki Nomura
Correspondent
Horiba, Ltd
2 Miyanohigashi, Kisshoin, Minami-ku
Kyoto,  JP 601-8510
Correspondent Contact Naoyuki Nomura
Regulation Number862.2160
Classification Product Code
JJE  
Subsequent Product Codes
CEM   CFR   CGZ   JGS  
Date Received12/06/2018
Decision Date 02/12/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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