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

Antigen, Inflammatory Response Marker, Sepsis

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

NTM is the FDA product code for Antigen, Inflammatory Response Marker, Sepsis, a class II device type, regulated under 21 CFR 866.3210. FDA's definition for this code reads: "An immunoluminometric assay used to determine the concentration of procalcitonin (pct) in human serum and plasma". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
NTM
Device name
Antigen, Inflammatory Response Marker, Sepsis
FDA definition
An immunoluminometric assay used to determine the concentration of procalcitonin (pct) in human serum and plasma.
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
3
Ingested recalls
2

Clearances, product code NTM

By decision year
3 clearances under product code NTM with a decision year between 2005 and 2008, 2005 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NTM by decision year
YearClearances
20051
20071
20081

Applicants with the most clearances

Product code NTM
Applicants holding the most 510(k) clearances under product code NTM
ApplicantClearances
Brahms Aktiengesellschaft2
bioMerieux, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code