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

Diagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune Disease

21 CFR 862.3100 / Clinical Toxicology
FDA source (opens on fda.gov)

NVI is the FDA product code for Diagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune Disease, a class II device type, regulated under 21 CFR 862.3100. FDA's definition for this code reads: "The device is intended to suggest a systemic autoimmune disease association as an aid for differential diagnosis to be evaluated in conjunction with clinical findings and other laboratory tests". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and one recall.

Classification record

Product code
NVI
Device name
Diagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune Disease
FDA definition
The device is intended to suggest a systemic autoimmune disease association as an aid for differential diagnosis to be evaluated in conjunction with clinical findings and other laboratory tests.
Regulation
21 CFR 862.3100
Device class
Class II
Review panel
Clinical Toxicology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
1
Ingested recalls
1

Clearances, product code NVI

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

Applicants with the most clearances

Product code NVI
Applicants holding the most 510(k) clearances under product code NVI
ApplicantClearances
Bio-Rad Laboratories Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code