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510(k) K033056

BUN REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA REAGENT by Diamond Diagnostics, Inc. — Product Code CDS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 2004
Date Received
September 29, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Ion Specific, Urea Nitrogen
Device Class
Class II
Regulation Number
862.1770
Review Panel
CH
Submission Type

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  • K812308 — LANCER BUN RATE REAGENT KIT (August 31, 1981)
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  • K800616 — BUN REAGENT KIT #88108 (April 10, 1980)
  • K800590 — BUN KIT (April 4, 1980)
  • K800071 — BUN REAGENT KIT (February 5, 1980)