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

Autoantibodies, Nuclear Body Protein, Sp100

21 CFR 866.5090 / Immunology
FDA source (opens on fda.gov)

NUM is the FDA product code for Autoantibodies, Nuclear Body Protein, Sp100, a class II device type, regulated under 21 CFR 866.5090. FDA's definition for this code reads: "THE DEVICE IS USED FOR THE DETECTION, IN HUMAN SERUM OR PLASMA, OF AUTOANTIBODIES TO SP100 (NUCLEAR BODY PROTEIN SP100) AS AN AID IN THE DIAGNOSIS OF PRIMARY BILIARY CIRRHOSIS". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
NUM
Device name
Autoantibodies, Nuclear Body Protein, Sp100
FDA definition
THE DEVICE IS USED FOR THE DETECTION, IN HUMAN SERUM OR PLASMA, OF AUTOANTIBODIES TO SP100 (NUCLEAR BODY PROTEIN SP100) AS AN AID IN THE DIAGNOSIS OF PRIMARY BILIARY CIRRHOSIS.
Regulation
21 CFR 866.5090
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
1
Ingested recalls
0

Clearances, product code NUM

By decision year
1 clearance under product code NUM with a decision year between 2005 and 2005, 2005 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NUM by decision year
YearClearances
20051

Applicants with the most clearances

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

Companies listing this code with FDA

Companies whose registered establishments list this code