GSP Neonatal Total Galactose Kit

FDA 510(k) K133652 · Wallac Oy, A Subsidiary of Perkinelmer, Inc.

Substantially Equivalent

510(k) numberK133652

Submission

Device name
GSP Neonatal Total Galactose Kit
Applicant
Wallac Oy, A Subsidiary of Perkinelmer, Inc.
Waltham, MA, US
Received
November 27, 2013
Decision date
April 28, 2014
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JIA – Enzymatic Methods, Galactose
Device class
Class I (low risk)
Regulation
21 CFR 862.1310
Specialty
Clinical Chemistry

Other 510(k)s with product code JIA

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K190335GSP Neonatal Total Galactose kitJIA · Traditional Perkinelmer, Inc.11/06/2019SE
K121101Spotcheck Neonatal Total Galactose Microplate Reagent KitJIA · Traditional Astoria-Pacific, Inc.06/20/2013SE
K071649Neonatal Total Galactose Kit; Neontal Total Galactose Kit, Models 3029-0010 and 3029-110BJIA · Traditional Wallac OY08/07/2008SE
K990654Quantase Total Galactose Screening Assay 500 Test KitJIA · Traditional Quantase , Ltd.06/21/1999SE
K990644Quantase Total Galactose Screening AssayJIA · Traditional Quantase , Ltd.06/21/1999SE
K991498Accuwell Total Galactose, Model 6010-EGALJIA · Traditional Neometrics, Inc.06/16/1999SE
K950481Neonatal Chemistry System, Galactose Test KitJIA · Traditional Isolab, Inc.02/01/1996SE
K951329Immuchem Gal-Mw EaJIA · Traditional Icn Pharmaceuticals, Inc.11/09/1995SE

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Questions and answers

When was GSP Neonatal Total Galactose Kit cleared by the FDA?

GSP Neonatal Total Galactose Kit (K133652) received a 510(k) decision of Substantially Equivalent on April 28, 2014, 152 days after the submission was received.

What is the product code of K133652?

The FDA product code is JIA – Enzymatic Methods, Galactose, a Class I (low risk) device regulated under 21 CFR 862.1310.