510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K173568Substantially Equivalent

NeoBase 2 Non-derivatized MSMS Kit

Wallac Oy, Subsidiary of Perkinelmer, Waltham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K173568 is the FDA 510(k) clearance record for NeoBase 2 Non-derivatized MSMS Kit, a class II device, cleared for Wallac Oy, Subsidiary of Perkinelmer, Inc. on under FDA product code NQL (System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry). FDA's definition for product code NQL 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...". FDA records list 2 510(k) clearances for Wallac Oy, Subsidiary of Perkinelmer, Inc., from to . As of , FDA records show no recalls naming K173568.

Clearance record

Decision date
Received
(288 days to decision)
Product code
NQL System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry
Regulation
21 CFR 862.1055
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Wallac Oy, Subsidiary of Perkinelmer, Inc. 940 Winter St., Waltham MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NQL

Trailing 12 months

FDA records hold no clearances under product code NQL in the trailing twelve months.

FDA records show no clearances under product code NQL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NQL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260