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510(k) K132462

S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE by Hitachi Chemical Diagnostics, Inc. — Product Code CDN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 2013
Date Received
August 7, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Urease, Photometric, Urea Nitrogen
Device Class
Class II
Regulation Number
862.1770
Review Panel
CH
Submission Type

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  • K972012 — CHOLESTECH BUN/CREATININE TEST SYSTEM (July 24, 1997)
  • K961196 — EKTACHEM CLINICAL CHEMISTRY UREA NITROGEN/UREA (BUN/UREA) (May 15, 1996)
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