Quantase Phe/Gal Screening Assay

Q: What is the product code of K984463?

The FDA product code is JNB – Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine, a Class II (moderate risk) device regulated under 21 CFR 862.1555.

FDA 510(k) K984463 · Quantase , Ltd.

Substantially Equivalent

510(k) numberK984463

Submission

Device name: Quantase Phe/Gal Screening Assay
Applicant: Quantase , Ltd.
Perth, Scotland, GB
Received: December 16, 1998
Decision date: February 16, 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: JNB – Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine
Device class: Class II (moderate risk)
Regulation: 21 CFR 862.1555
Specialty: Clinical Chemistry

Other 510(k)s with product code JNB

510(k)	Device	Applicant	Decision
K021541	Neogram Pku Tandem Mass Spectrometry KitJNB · Traditional	Perkinelmer Life Sciences	10/28/2002SE
K003584	Neolynx Screening Application ManagerJNB · Traditional	Micromass, Inc.	03/19/2001SE
K000754	Quantase Phenylalanine Screening Assay 500 Test KitJNB · Traditional	Quantase , Ltd.	06/19/2000SE
K982307	Wallac Neonatal Leucine Test Kit Model NL-1000JNB · Traditional	Wallac, Inc.	02/02/1999SE
K974047	Accuwell Phenylalanine AssayJNB · Traditional	Neometrics, Inc.	12/05/1997SE
K963040	Manual Phenylalanine TestJNB · Traditional	Bio-Rad	10/01/1996SE
K960437	Radias Phenylalanine TestJNB · Traditional	Bio-Rad	08/16/1996SE
K961515	Quantase Phenylalanine AssayJNB · Traditional	Shield Diagnostics, Ltd.	06/12/1996SE
K943547	Phenylalanine Test KitJNB · Traditional	Isolab, Inc.	01/26/1996SE
K926106	Immuchem Phe-Mw EaJNB · Traditional	Icn Biomedicals, Inc.	02/08/1995SE

More from Icn Biomedicals, Inc.

510(k)	Device	Decision
K000754	Quantase Phenylalanine Screening Assay 500 Test KitJNB · Traditional	06/19/2000SE
K990654	Quantase Total Galactose Screening Assay 500 Test KitJIA · Traditional	06/21/1999SE
K990644	Quantase Total Galactose Screening AssayJIA · Traditional	06/21/1999SE

Questions and answers

When was Quantase Phe/Gal Screening Assay cleared by the FDA?

Quantase Phe/Gal Screening Assay (K984463) received a 510(k) decision of Substantially Equivalent on February 16, 1999, 62 days after the submission was received.

What is the product code of K984463?

The FDA product code is JNB – Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine, a Class II (moderate risk) device regulated under 21 CFR 862.1555.