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

System, Test, Her-2/Neu, Monitoring

21 CFR 866.6010 / Immunology
FDA source (opens on fda.gov)

NCW is the FDA product code for System, Test, Her-2/Neu, Monitoring, a class II device type, regulated under 21 CFR 866.6010. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
NCW
Device name
System, Test, Her-2/Neu, Monitoring
Regulation
21 CFR 866.6010
Device class
Class II
Review panel
Immunology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
3
Ingested recalls
1

Clearances, product code NCW

By decision year
3 clearances under product code NCW with a decision year between 2000 and 2003, 2000 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code NCW by decision year
YearClearances
20002
20031

Applicants with the most clearances

Product code NCW
Applicants holding the most 510(k) clearances under product code NCW
ApplicantClearances
Bayer Corp.2
Oncogene Science, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code