510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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CHNClass II

Immunochemical, Ceruloplasmin

21 CFR 866.5210 / Immunology
FDA source (opens on fda.gov)

CHN is the FDA product code for Immunochemical, Ceruloplasmin, a class II device type, regulated under 21 CFR 866.5210. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and 6 recalls.

Classification record

Product code
CHN
Device name
Immunochemical, Ceruloplasmin
Regulation
21 CFR 866.5210
Device class
Class II
Review panel
Immunology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
6

Clearances, product code CHN

By decision year
3 clearances under product code CHN with a decision year between 2007 and 2010, 2007 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code CHN by decision year
YearClearances
20072
20101

Applicants with the most clearances

Product code CHN
Applicants holding the most 510(k) clearances under product code CHN
ApplicantClearances
Roche Diagnostics GmbH2
Siemens Healthcare Diagnostics Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code