NEOGRAM PKU TANDEM MASS SPECTROMETRY KIT— 510(k) K021541

Clearance details

Applicant

Perkinelmer Life Sciences

Product code

Code JNB

Device class

Class 2

Regulation

21 CFR 862.1555

Advisory panel

Clinical Chemistry

Date received

2002-05-10

Decision date

2002-10-28

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Norton, OH, US

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• Z-0686-2013 — NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT Product Number: 3026-0030. This kit is intended for the measurement and evaluation of amino acid, free carnitine, and acylcarnitine concentrations from newborn heel prick blood samples dried on filter paper. (Table 1 of Attachment 2) details the analytes measured by the kit. Quantitative analysis of amino acids, free carnitine and acylcarnitines and their relationship with each other is intended to provide analyte concentration profiles that may aid in the screening of newborns for one or more of several metabolic disorders. This kit is to be used for in vitro diagnostic use only, by trained, qualified laboratory personnel.Class II·Terminated·Perkinelmer·20121126

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K021541.