Product code CHN— Immunology

CERULOPLASMIN, MODEL 2055953

Classification name: Immunochemical, Ceruloplasmin
Device class: Class 2
Regulation: 21 CFR 866.5210
Advisory panel: Immunology
Total cleared: 3
First cleared: 2007-01-31
Most recent: 2010-03-18

Market context for product code CHN

FDA has cleared 3 devices under product code CHN between 2007 and 2010, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

20101 clearance
20072 clearances

Top applicants under product code CHN

Roche Diagnostics Corp.1 clearance
Roche Diagnostics1 clearance
Dade Behring, Inc.1 clearance

Recent clearances under product code CHN

K091741 — TINA-QUANT CERULOPLASMINRoche Diagnostics·2010-03-18
K063655 — DIMENSION VISTA; CER FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, PROTEIN 1 CONTROL HIGHDade Behring, Inc.·2007-02-15
K062114 — CERULOPLASMIN, MODEL 2055953Roche Diagnostics Corp.·2007-01-31

Data sourced from openFDA. This site is unofficial and independent of the FDA.