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

Assay, Endotoxin Activity, Chemiluminescent

21 CFR 866.3210 / Microbiology
FDA source (opens on fda.gov)

NGS is the FDA product code for Assay, Endotoxin Activity, Chemiluminescent, a class II device type, regulated under 21 CFR 866.3210. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
NGS
Device name
Assay, Endotoxin Activity, Chemiluminescent
Regulation
21 CFR 866.3210
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code NGS

By decision year
2 clearances under product code NGS with a decision year between 2003 and 2019, 2003 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NGS by decision year
YearClearances
20031
20191

Applicants with the most clearances

Product code NGS
Applicants holding the most 510(k) clearances under product code NGS
ApplicantClearances
Spectral Diagnostics, Inc.1
Spectral Medical Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code