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510(k) K161297

Beta-2-Microglobulin by Beckman Coulter Ireland, Inc. — Product Code JZG

K161297 is an FDA 510(k) premarket notification submitted by Beckman Coulter Ireland, Inc. for the device "Beta-2-Microglobulin". The FDA issued a decision of Substantially Equivalent on June 7, 2016. The device falls under product code JZG (System, Test, Beta-2-Microglobulin Immunological), a Class II device regulated under 21 CFR 866.5630. Beckman Coulter Ireland, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 2016
Date Received
May 9, 2016
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Beta-2-Microglobulin Immunological
Device Class
Class II
Regulation Number
866.5630
Review Panel
IM
Submission Type

Other clearances by Beckman Coulter Ireland, Inc.

  • K182651 — HbA1c Advanced (January 16, 2019)
  • K161508 — Ceruloplasmin (January 9, 2017)
  • K142346 — Urine/CSF Albumin, Urine/CSF Albumin Calibrator (October 15, 2014)
  • K141388 — SYSTEM CALIBRATER (July 11, 2014)
  • K141374 — BICARBONATE CALIBRATOR (June 30, 2014)
  • K131546 — AU BICARBONATE REAGENT (October 9, 2013)

Other clearances for product code JZG

  • K122066 — HUMAN BETA-2 MICROGLOBULIN URINE KIT FOR USE ON THE SPAPLUS (August 30, 2012)
  • K110874 — ADVIA CHEMISTRY REAGENTS, AND ADVIA CHEMISTRY B2-MICROGLOBULIN CALIBRATOR (January 20, 2012)
  • K083289 — HUMAN BETA-2 MICROGLOBULIN KIT (May 6, 2009)
  • K083463 — DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, DIME (March 13, 2009)
  • K072078 — QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307 (December 19, 2007)
  • K063272 — DIMENSION VISTA B2MIC FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL MEDI (January 26, 2007)
  • K050613 — QUANTIA BETA-2 MICROGLOBULIN (August 16, 2005)
  • K032692 — DAKOCYTOMATION BETA-2-MICROGLOBULIN KIT, CODE NO. OA 368 (January 22, 2004)
  • K014270 — MININEPH HUMAN B2-MICROGLOBULIN KIT (August 15, 2002)
  • K002731 — N LATEX B2-MICROGLOBULIN (November 20, 2000)

FDA data resources