Quantase Total Galactose Screening Assay

FDA 510(k) K990644 · Quantase , Ltd.

Substantially Equivalent

510(k) numberK990644

Submission

Device name
Quantase Total Galactose Screening Assay
Applicant
Quantase , Ltd.
Perth, Scotland, GB
Received
February 26, 1999
Decision date
June 21, 1999
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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

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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
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

More from Icn Pharmaceuticals, Inc.

510(k)DeviceDecision
K000754Quantase Phenylalanine Screening Assay 500 Test KitJNB · Traditional 06/19/2000SE
K990654Quantase Total Galactose Screening Assay 500 Test KitJIA · Traditional 06/21/1999SE
K984463Quantase Phe/Gal Screening AssayJNB · Traditional 02/16/1999SE

Questions and answers

When was Quantase Total Galactose Screening Assay cleared by the FDA?

Quantase Total Galactose Screening Assay (K990644) received a 510(k) decision of Substantially Equivalent on June 21, 1999, 115 days after the submission was received.

What is the product code of K990644?

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