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

Immunoassay, Anti-Seizure Drug

21 CFR 862.3350 / Clinical Toxicology
FDA source (opens on fda.gov)

NWM is the FDA product code for Immunoassay, Anti-Seizure Drug, a class II device type, regulated under 21 CFR 862.3350. FDA's definition for this code reads: "To aid in management of patients treated with anti-seizure drug". As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
NWM
Device name
Immunoassay, Anti-Seizure Drug
FDA definition
To aid in management of patients treated with anti-seizure drug.
Regulation
21 CFR 862.3350
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
5
Ingested recalls
0

Clearances, product code NWM

By decision year
5 clearances under product code NWM with a decision year between 2005 and 2021, 2009 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code NWM by decision year
YearClearances
20051
20071
20092
20211

Applicants with the most clearances

Product code NWM
Applicants holding the most 510(k) clearances under product code NWM
ApplicantClearances
Ark Diagnostics Inc3
Seradyn, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code