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510(k) K161508

Ceruloplasmin by Beckman Coulter Ireland, Inc. — Product Code DDB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 2017
Date Received
June 1, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ceruloplasmin, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5210
Review Panel
IM
Submission Type

Other clearances by Beckman Coulter Ireland, Inc.

  • K182651 — HbA1c Advanced (January 16, 2019)
  • K161297 — Beta-2-Microglobulin (June 7, 2016)
  • 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 DDB

  • K122965 — HUMAN CAERULOPLASMIN KIT (June 3, 2013)
  • K053074 — N ANTISERA TO HUMAN CERULOPLASMIN (March 16, 2006)
  • K964762 — IMMAGE IMMUNOCHEMISTRY SYSTEM CERULOPLASMIN (CER) REAGENT (April 25, 1997)
  • K913668 — CAERULOPLASMIN IMMUNOLOGICAL NL TEST KIT (December 20, 1991)
  • K895377 — QM300 CERULOPLASMIN ANTIBODY PACK (September 21, 1989)
  • K860138 — NO. 615 DETERMINATION OF CERULOPLASMIN IN SERUM (March 28, 1986)
  • K850682 — 72 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL (November 25, 1985)
  • K852247 — LASER CERULOPLASMIN KIT(CERULOPLASMIN REAGENTS) (July 10, 1985)
  • K851283 — RADIAL IMMUNODIFFUSION PLATES-CERULOPLASMIN (May 23, 1985)
  • K823107 — QUANTIMETRIC 2 CERULOPLASMIN ASSAY (November 16, 1982)