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510(k) K053074

N ANTISERA TO HUMAN CERULOPLASMIN by Dade Behring, Inc. — Product Code DDB

K053074 is an FDA 510(k) premarket notification submitted by Dade Behring, Inc. for the device "N ANTISERA TO HUMAN CERULOPLASMIN". The FDA issued a decision of Substantially Equivalent on March 16, 2006. The device falls under product code DDB (Ceruloplasmin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5210. Dade Behring, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 2006
Date Received
November 1, 2005
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 Dade Behring, Inc.

  • K093848 — PT-MULTI-CALIBRATOR, MODEL OPAT07 (December 20, 2010)
  • K081161 — DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEI (July 28, 2008)
  • K081249 — DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROT (July 21, 2008)
  • K071603 — DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA) (June 25, 2008)
  • K071597 — DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (June 4, 2008)
  • K073604 — DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CAR (March 13, 2008)
  • K073561 — DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION VISTA (February 26, 2008)
  • K073072 — DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B (February 21, 2008)
  • K073055 — DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270 (January 3, 2008)
  • K072965 — DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON (December 21, 2007)

Other clearances for product code DDB

  • K161508 — Ceruloplasmin (January 9, 2017)
  • K122965 — HUMAN CAERULOPLASMIN KIT (June 3, 2013)
  • 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)

FDA data resources