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510(k) K141374

BICARBONATE CALIBRATOR by Beckman Coulter Ireland, Inc. — Product Code JIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 2014
Date Received
May 27, 2014
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Secondary
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

Other clearances by Beckman Coulter Ireland, Inc.

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  • K161508 — Ceruloplasmin (January 9, 2017)
  • K161297 — Beta-2-Microglobulin (June 7, 2016)
  • K142346 — Urine/CSF Albumin, Urine/CSF Albumin Calibrator (October 15, 2014)
  • K141388 — SYSTEM CALIBRATER (July 11, 2014)
  • K131546 — AU BICARBONATE REAGENT (October 9, 2013)

Other clearances for product code JIT

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  • K170938 — CalSet IGF-1 (April 26, 2017)
  • K170160 — Abbott ARCHITECT Free T3 (February 15, 2017)
  • K163534 — Lumipulse G FSH-N Calibrators (January 13, 2017)
  • K163546 — Lumipulse G Progesterone-N Calibrators (January 13, 2017)
  • K163521 — Lumipulse G LH Calibrators (January 12, 2017)
  • K163544 — Lumipulse G Prolactin (January 12, 2017)
  • K163078 — DC-UIBC-CAL (December 8, 2016)
  • K163053 — Lumipulse G E2-III Calibrators (December 1, 2016)
  • K162538 — ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Cal (November 17, 2016)