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510(k) K761061

BLOOD-UREA-NITROGEN (BUN) ANALYZER 2 by Beckman Instruments, Inc. — Product Code CDS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 1977
Date Received
November 18, 1976
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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Other clearances for product code CDS

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  • K040973 — BUN REAGENT (December 27, 2004)
  • K033056 — BUN REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA REAGENT (January 30, 2004)
  • K925550 — HI CHEM BUN REAGENT KIT,PRODUCT NUMBER 88806 (April 20, 1993)
  • K860543 — BLOOD UREA NITROGEN (BUN) TESTCARD (April 21, 1986)
  • K855091 — CHEM-PRO 1000 CLINICAL CHEMISTRY-ANALYSIS SYS (March 14, 1986)
  • K812308 — LANCER BUN RATE REAGENT KIT (August 31, 1981)
  • K811193 — BUN RATE REAGENT (July 10, 1981)
  • K800616 — BUN REAGENT KIT #88108 (April 10, 1980)
  • K800590 — BUN KIT (April 4, 1980)