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

Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1)

21 CFR 866.5660 / Immunology
FDA source (opens on fda.gov)

NBS is the FDA product code for Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1), a class II device type, regulated under 21 CFR 866.5660. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
NBS
Device name
Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1)
Regulation
21 CFR 866.5660
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
0

Clearances, product code NBS

By decision year
3 clearances under product code NBS with a decision year between 2000 and 2017, 2000 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NBS by decision year
YearClearances
20001
20121
20171

Applicants with the most clearances

Product code NBS
Applicants holding the most 510(k) clearances under product code NBS
ApplicantClearances
Inova Diagnostics, Inc.2
Euroimmun US Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code