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

System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry

21 CFR 862.1055 / Clinical Chemistry
FDA source (opens on fda.gov)

NQL is the FDA product code for System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry, a class II device type, regulated under 21 CFR 862.1055. FDA's definition for this code reads: "Amino acids, free carnitines and acylcarnitines test system is intended for the measurement and evaluation of amino acid, free carnitine and acylcarnitine concentrations from newborn whole blood filter paper samples. The quantitative analysis of the amino acids, free carnitines and acylcarnitines and their...". As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
NQL
Device name
System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry
FDA definition
Amino acids, free carnitines and acylcarnitines test system is intended for the measurement and evaluation of amino acid, free carnitine and acylcarnitine concentrations from newborn whole blood filter paper samples. The quantitative analysis of the amino acids, free carnitines and acylcarnitines and their relationship with each other is intended to provide analyte concentration profiles that should aid in identifying elevated levels of these metabolites for screening newborns for one or more of several metabolic disorders.
Regulation
21 CFR 862.1055
Device class
Class II
Review panel
Clinical Chemistry
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
5
Ingested recalls
3

Clearances, product code NQL

By decision year
5 clearances under product code NQL with a decision year between 2004 and 2020, 2004 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NQL by decision year
YearClearances
20041
20091
20101
20181
20201

Applicants with the most clearances

Product code NQL
Applicants holding the most 510(k) clearances under product code NQL
ApplicantClearances
Revvity Health Sciences, Inc.4
Wallac Oy, Subsidiary of Perkinelmer1

Companies listing this code with FDA

Companies whose registered establishments list this code