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

System, Test, (Ihc), Tumor Marker, Monitoring, Bladder Cancer

21 CFR 864.1860 / Hematology
FDA source (opens on fda.gov)

NBK is the FDA product code for System, Test, (Ihc), Tumor Marker, Monitoring, Bladder Cancer, a class II device type, regulated under 21 CFR 864.1860. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
NBK
Device name
System, Test, (Ihc), Tumor Marker, Monitoring, Bladder Cancer
Regulation
21 CFR 864.1860
Device class
Class II
Review panel
Hematology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code NBK

By decision year
1 clearance under product code NBK with a decision year between 2000 and 2000, 2000 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NBK by decision year
YearClearances
20001

Applicants with the most clearances

Product code NBK
Applicants holding the most 510(k) clearances under product code NBK
ApplicantClearances
Diagnocure, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code NBK.