Wallac Neonatal Leucine Test Kit Model NL-1000
FDA 510(k) K982307 · Wallac, Inc.
510(k) numberK982307
Submission
- Device name
- Wallac Neonatal Leucine Test Kit Model NL-1000
- Applicant
- Wallac, Inc.
Norton, OH, US - Received
- July 1, 1998
- Decision date
- February 2, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| 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 |
|---|---|---|
| K131284 | GSP Neonatal Biotinidase KitNAK · Traditional | 11/14/2013SE |
| K100682 | GSP Neonatal 17A-OH-PROGESTERONE Kit Model: 3305-001UJLX · Traditional | 07/23/2010SE |
| K081922 | Autodelfia Neonatal 17A-OH-PROGESTERONE KitJLX · Traditional | 04/16/2009SE |
| K071649 | Neonatal Total Galactose Kit; Neontal Total Galactose Kit, Models 3029-0010 and 3029-110BJIA · Traditional | 08/07/2008SE |
| K070889 | Autodelfia Neonatal Irt L Kit, Model B022-112CGZ · Traditional | 04/14/2008SE |
| K050709 | Resolve Hemoglobin Kit, JB-2 Staining System, Models FR-9120, FR-9400, FR-9360, FR-9367GKA · Traditional | 03/08/2006SE |
| K050960 | Modification to: Autodelfia Neonatal 17A-OH-PROGESTERONE L KitJLX · Special | 07/11/2005SE |
| K042425 | Autodelfia Neonatal 17A-OH-PROGESTERONE KitJLX · Special | 09/30/2004SE |
| K042424 | Delfia Neonatal 17A-OH-PROGESTERONE KitJLX · Special | 09/30/2004SE |
| K003664 | Delfia Neonatal Irt Kit, Model A005-110CGZ · Traditional | 02/14/2001SE |
Questions and answers
When was Wallac Neonatal Leucine Test Kit Model NL-1000 cleared by the FDA?
Wallac Neonatal Leucine Test Kit Model NL-1000 (K982307) received a 510(k) decision of Substantially Equivalent on February 2, 1999, 216 days after the submission was received.
What is the product code of K982307?
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.