Immuchem Phe-Mw Ea

Q: When was Immuchem Phe-Mw Ea cleared by the FDA?

Immuchem Phe-Mw Ea (K926106) received a 510(k) decision of Substantially Equivalent on February 8, 1995, 797 days after the submission was received.

Q: What is the product code of K926106?

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) K926106 · Icn Biomedicals, Inc.

Substantially Equivalent

510(k) numberK926106

Submission

Device name: Immuchem Phe-Mw Ea
Applicant: Icn Biomedicals, Inc.
Costa Mesa, CA, US
Received: December 3, 1992
Decision date: February 8, 1995
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
K984463	Quantase Phe/Gal Screening AssayJNB · Traditional	Quantase , Ltd.	02/16/1999SE
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

More from Isolab, Inc.

510(k)	Device	Decision
K030211	Rapid Barbiturate Test Strip and Test Card, Models 7015 and 7016DKX · Traditional	06/13/2003SE
K023252	Rapid Methadone Test Strip, Model 7019 & Rapid Methadone Test Card, Model 7020DJR · Traditional	11/22/2002SE
K922944	Immuchem Lh-Mw ElisaCEP · Traditional	02/02/1993SE
K922715	Immuchem Prl-Mw ElisaCFT · Traditional	10/05/1992SE
K922376	Icn Biomedicals Immuchem(Tm) Fsh-Mw Elisa KitCGJ · Traditional	10/05/1992SE
K920442	Immuchem Tsh-Mw ElisaJLW · Traditional	03/18/1992SE
K913963	Immuchem Neonatal Tsh-Mp ElisaJLW · Traditional	12/13/1991SE
K902445	Lympho Sep(Tm)JCF · Traditional	08/22/1990SE
K885198	17-ALPHA-HYDROXYPROGESTERONE (17-OH-P) Neo. RiaJLX · Traditional	02/23/1989SE
K881005	Immuchem Human Chorionic Gonadotropin Hormone HCGJHI · Traditional	05/27/1988SE

Questions and answers

When was Immuchem Phe-Mw Ea cleared by the FDA?

Immuchem Phe-Mw Ea (K926106) received a 510(k) decision of Substantially Equivalent on February 8, 1995, 797 days after the submission was received.

What is the product code of K926106?

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.