Radias Phenylalanine Test
FDA 510(k) K960437 · Bio-Rad
510(k) numberK960437
Submission
- Device name
- Radias Phenylalanine Test
- Applicant
- Bio-Rad
Hercules, CA, US - Received
- January 31, 1996
- Decision date
- August 16, 1996
- 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 |
| 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 |
| 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 |
|---|---|---|
| K171061 | MRSASelect IIJSO · Traditional | 12/28/2017SE |
| K122187 | Vreselect Culture MediumJSO · Traditional | 11/06/2012SE |
| K103684 | Vreselect Culture MediumJSO · Traditional | 10/21/2011SE |
| K093678 | Platelia Aspergillus Eia Model 62793NOM · Traditional | 01/13/2011SE |
| K100589 | Mrsa Select - Skin and Soft Tissue Wound SpecimensJSO · Traditional | 10/29/2010SE |
| K081362 | Platelia Lyme IgmLSR · Traditional | 06/26/2008SE |
| K081212 | Mrsaselect - Extended IncubationJSO · Traditional | 06/13/2008SE |
| K080012 | Platelia Lyme Igg AssayLSR · Traditional | 05/08/2008SE |
| K070361 | MrsaselectJSO · Traditional | 09/13/2007SE |
| K060641 | Platelia Aspergillus Eia, Model 62793NOM · Traditional | 06/02/2006SE |
Questions and answers
When was Radias Phenylalanine Test cleared by the FDA?
Radias Phenylalanine Test (K960437) received a 510(k) decision of Substantially Equivalent on August 16, 1996, 198 days after the submission was received.
What is the product code of K960437?
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.