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510(k) K142346

Urine/CSF Albumin, Urine/CSF Albumin Calibrator by Beckman Coulter Ireland, Inc. — Product Code DCF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 2014
Date Received
August 22, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Albumin, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5040
Review Panel
IM
Submission Type

Other clearances by Beckman Coulter Ireland, Inc.

  • K182651 — HbA1c Advanced (January 16, 2019)
  • K161508 — Ceruloplasmin (January 9, 2017)
  • K161297 — Beta-2-Microglobulin (June 7, 2016)
  • K141388 — SYSTEM CALIBRATER (July 11, 2014)
  • K141374 — BICARBONATE CALIBRATOR (June 30, 2014)
  • K131546 — AU BICARBONATE REAGENT (October 9, 2013)

Other clearances for product code DCF

  • K153560 — Optilite Low Level Albumin Kit (August 25, 2016)
  • K143118 — Human Microalbumin kit for use on SPAPLUS (May 26, 2015)
  • K121045 — HUMAN ALBUMIN CSF KIT (June 19, 2013)
  • K113072 — TINA-QUANT ALBUMIN GEN.2 (May 14, 2012)
  • K101089 — EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR (July 13, 2011)
  • K101203 — TINA-QUANT ALBUMIN GEN 2 (September 10, 2010)
  • K100853 — COBAS 8000 MODULAR SERIES ANALYZER (September 9, 2010)
  • K091486 — K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR (April 29, 2010)
  • K082251 — SYNCHRON SYSTEMS MICROALBUMIN (MA) REAGENT, MODEL 475100 (April 8, 2009)
  • K061990 — DIMENSION VISTA MICROALBUMIN FLEX REAGENT CARTRIDGE; PROTEIN 3 CALIBRATOR; PROTE (September 19, 2006)